Patients with longstanding psoriatic arthritis can achieve DAPSA remission or low disease activity and it correlates to better functional outcomes: results from a Latin-American real-life cohort

Abstract Background Patients with psoriatic arthritis (PsA) experience reduced physical function and impaired quality of life. Better patient-reported functional outcomes are found when lower disease activity is achieved. Objectives To evaluate the variation of physical function by HAQ-DI over time in PsA patients treated with standard therapy in a real-life setting: to verify predictors of achieving a minimum clinically important difference (MCID) in function by HAQ-DI (ΔHAQ-DI ≤ − 0.35) and to measure the impact of achieving REM/LDA on long-term function by HAQ-DI. Methods This is a longitudinal analysis of a real-life retrospective cohort. Data from PsA patients with at least 4 years of follow-up in the PsA clinic from 2011 to 2019 were extracted from electronic medical records. The variations of physical function by HAQ-DI and disease activity by DAPSA over time were calculated. A multivariate hierarchical regression model was applied to verify predictors of MCID in HAQ-DI. A comparison of HAQ-DI variation between patients with DAPSA REM, LDA, moderate and high disease activity was made using the generalized estimating equation model (GEE), adjusted by Bonferroni test. The Spearman correlation method was applied to verify the correlation of ΔDAPSA and ΔHAQ-DI over time. Statistical analysis was performed in SPSS program version 21.0. Results Seventy-three patients were included in the analysis. Physical function measured by HAQ-DI was determined by PsA disease activity measured by DAPSA (p < 0.000). A moderate and statistically significant correlation between ΔDAPSA and ΔHAQ-DI was observed (rs = 0.60; p < 0.001). Only patients in DAPSA REM demonstrated a constant decline in HAQ-DI scores during the follow-up. White ethnicity and older age at baseline were predictors for not achieving MCID in HAQ-DI [RR 0.33 (0.16-0.6795% CI p = 0.002) and RR 0.96 (0.93-0.9895% CI p < 0.000), respectively, while higher scores of HAQ-DI at baseline were predictors of achieving MCID [RR 1.71 (1.12-2.6095%CI p = 0.013)]. Conclusion In PsA, patients who maintained DAPSA REM/LDA over time had better long-term functional outcomes. Higher HAQ-DI scores at baseline, non-white ethnicity and younger age were predictors for achieving a clinical meaningful improvement of HAQ-DI.

4-domain sports prom translation and cultural adaptation into portuguese / 4-domain sports prom: traducción y adaptación cultural al portugués / 4-domain sports prom: tradução e adaptação cultural para a língua portuguesa

ABSTRACT Introduction: The literature presents several scientifically validated and cross-culturally adapted questionnaires in the area of orthopedics and Sports Medicine scientifically validated and cross-culturally adapted. However, they are anatomically specific, and do not consider the specific needs of athletes. The "4-Domain PROM for Orthopedic and Sports Medicine" (4-Domain Sports PROM) is the first questionnaire, in the literature (International Journal of Sports Medicine - 2021), designed to assess athletes and highly active sports practitioners, and their specificities. physical and psychological. It comprises four domains: athlete without injury, after sports injury, expectation of treatment, athlete's assessment of the treatment received. Objectives: This work aims to carry out the translation and cross-cultural adaptation (TCA) to the Portuguese language. Methods: The questionnaire was self-administered by 50 participants, regular physical and sports activities practitioners. The translation and cultural adaptation process involved six steps: translation; synthesis; back translation; pre-test; review by the Expert Committee, clinical application and author approval of the original version. The Equivalence of translation and relevance of questionnaire items were evaluated. RESULTS: The Portuguese version of the 4-DOMAIN SPORTS PROM had a translation equivalence of 0.94, and item relevance was 0.98, while the percentage of agreement between patients for understanding was 0.98. Conclusion: The translation and cross-cultural adaptation of the 4 Domain Sports PROM into the Portuguese version proved to be understandable and reproducible in all questionnaire domains (agreement above 90% and content validity index of 100%) to assess the treatment of the population of athletes and regular sports practitioners. Level of Evidence II; A cross-sectional qualitative study.

RESUMEN Introducción: La literatura presenta varios cuestionarios científicamente validados y transculturalmente adaptados en el área de la ortopedia y Medicina del Deporte. Sin embargo, son anatómicamente específicos y no consideran las necesidades específicas de los atletas. El "4-Domain PROM for Orthopaedic and Sports Medicine" (4-Domain Sports PROM) es el primer cuestionario, en la literatura (International Journal of Sports Medicine - 2021), diseñado para evaluar atletas y practicantes de deportes altamente activos, y sus especificidades físicas y psicológicas. Comprende cuatro dominios: atleta sin lesión, después de una lesión deportiva, expectativa de tratamiento, evaluación del atleta sobre el tratamiento recibido. Objetivos: El objetivo de este trabajo es realizar la traducción y adaptación transcultural (TCA) a la lengua portuguesa. Métodos: El cuestionario fue autoadministrado por 50 participantes, practicantes habituales de actividades físicas y deportivas. El proceso de traducción y adaptación cultural involucró seis pasos: traducción; síntesis; traducción inversa; prueba previa; revisión por el comité de expertos; aplicación clínica y aprobación del autor de la versión original. Se evaluaron la equivalencia de traducción y la relevancia de los ítems del cuestionario. Resultados: La versión portuguesa del 4-DOMAIN SPORTS PROM tuvo una equivalencia de traducción de 0,94 y la relevancia de los ítems fue de 0,98, mientras que el porcentaje de acuerdo entre los pacientes para la comprensión fue de 0,98. Conclusión: La traducción y adaptación transcultural del 4-DOMAIN SPORTS PROM al portugués amplía las posibilidades de evaluar los diferentes momentos que involucran el tratamiento de lesiones deportivas, ya que este cuestionario fue diseñado para capturar datos sobre la percepción de los pacientes antes de la lesión, después de la lesión, expectativa y evaluación del trato recibido en deportistas y practicantes habituales de actividad física. Nivel de Evidencia II; Estudio Cualitativo Transversal.

RESUMO Introdução: A literatura apresenta diversos questionários cientificamente validados e adaptados transculturalmente na área de na Ortopedia e Medicina Esportiva validados cientificamente e adaptados transculturalmente. Entretanto, eles são anatomicamente específicos, e não consideram as necessidades especificas dos atletas. O "4-Domain PROM for Orthopedic and Sports Medicine" (4-Domain Sports PROM) é o primeiro questionário, na literatura (International Journal of Sports Medicine - 2021), concebido para avaliar atletas e praticantes de esportes altamente ativos, e suas especificidades físicas e psicológicas. Ele compreende quatro domínios: atleta sem lesão, após lesão esportiva, expectativa do tratamento, avaliação do atleta sobre o tratamento recebido. Objetivos: O objetivo deste trabalho é realizar a tradução e a adaptação transcultural (TCA) à língua portuguesa. Métodos: O questionário foi autoadministrado por 50 participantes, praticantes regulares de atividades físicas e esportivas. O processo de tradução e adaptação cultural envolveu seis etapas: tradução; síntese; retrotradução; pré-teste; revisão pelo comitê de experts; aplicação clínica e aprovação do autor da versão original. Foi avaliado a Equivalência da tradução e relevância de itens do questionário. Resultados: A versão em português do 4-DOMAIN SPORTS PROM apresentou equivalência da tradução de 0,94 e relevância dos itens foi de 0,98, enquanto a porcentagem de concordância entre os pacientes para compreensão foi de 0,98. Conclusão: A tradução e adequação cultural do 4-DOMAIN SPORTS PROM para língua portuguesa mostrou-se compreensível e reprodutibilidade adequada em todos os domínios do questionário (concordância acima de 90% e Índice de Validade de Conteúdo de 100%) para avaliar o tratamento de população de indivíduos atletas e praticantes regulares de esportes. Nível de Evidência II; Estudo Qualitativo Transversal.

Long-term visual acuity results from cataract surgery and its association with self-reported visual function: Catquest applicability / Resultados acuidade visual a longo prazo da cirurgia de catarata e sua associação com função visual autorreferida: aplicabilidade do Catquest

ABSTRACT Purposes: This study aimed to determine the association of the long-term refractive outcomes of cataract surgery with self-reported visual function obtained using Catquest-9SF. Methods: Patients recruited from the cataract outpatient clinic of VER MAIS Oftalmologia underwent a complete ophthalmologic examination. Patients who were diagnosed with cataract with indications for phacoemulsification and intraocular lens implantation received the Catquest-9SF questionnaire before and after surgery at 30 days and 1 year. Results: A total of 133 patients were recruited, but 32 patients were lost to follow-up; finally, data from 101 patients (48 men, 53 women) were analyzed. The crude variance explained by the data was 69.9%, and the unexplained variance in the first contrast was 2.39 eigenvalues (>2); thus, these results are different from those expected from random data. The people separation index was 2.95 (>2), and the people trust value was 0.9 (>0.8). These indices were evaluated in the assessment of skill levels. Visual acuity was the main variable that correlated with the Catquest score. Conclusions: The Catquest-9SF translated into Portuguese proved to be a one-dimensional and psychometrically valid tool to assess visual dysfunction in patients with cataract, and it is successful in objectively quantifying improvements after surgery. The results of this tool could be predictive and concordant of visual acuity improvement.

RESUMO Objetivo: Associar os resultados refrativos a longo prazo da cirurgia de catarata e a função visual autorreferida pelo questionário Catquest-9SF. Métodos: Paciente recrutados no ambulatório de catarata da VER MAIS Oftalmologia, foram submetidos a exame oftalmológico completo. Após diagnóstico de catarata com indicação de tratamento cirúrgico com facoemulsificação e implante de lente intraocular, o questionário foi aplicado antes da intervenção, 30 dias após cirurgia e 1 ano após, novamente. Resultados: Foram recrutados 133 pacientes. No decorrer do seguimento, 32 pacientes foram perdidos e ao final foram analisados os dados de 101 pacientes, dos quais 48 foram homens e 53 foram mulheres. A variância bruta explicada por dados foi de 69,9% e a inexplicada em primeiro contraste por 2,39 eigenvalores, sendo maior que 2, o que nos mostra que são resultados differentes dos esperados de dados aleatórios. O índice de separação de pessoas foi de 2.95 (>2) e o valor de confiança de pessoas foi de 0,9 (>0,8). Estes índices são os valores mínimos aceitáveis na diferenciação de níveis de habilidade. Acuidade visual foi a principal variável correlacionada com o score do Catquest. Conclusões: O Catquest-9SF traduzido para o português se demonstrou unidimensional e uma ferramenta psicometricamente válida para avaliar disfunção visual em pacientes com catarata, além de ter tido sucesso para quantificar objetivamente melhoras após a intervenção cirúrgica. Essa ferramenta pode ser utilizada como preditiva e concordante da melhora da acuidade visual.

Corrélation of EQ-5D and mRS in ischémie stroke: a multicenter cross-sectional study

Introduction: Assessing Health-Related Quality of Life (HRQOL), in addition to evaluating functional status in stroke patients could complement clinician practice. Objective: To assess HRQOL, applying EuroQol-5-dimensions (EQ-5D) in Colombian patients with stroke and correlating its results with the modified Rankin Scale (mRS). Methods: Analytical cross-sectional study in a cohort of ischemic stroke patients in Colombia at three months as a median follow-up (Q1: 1- Q3:3) after their event. We correlated EQ-5D domains, EQ-5D index, mRS with EQ-5D VAS score. We generated a simple linear regression robust model to evaluate the variability between using r2. Results: A total of 91 patients completed the EQ-5D questionnaire, with a mean age of 71.2 years; 59.3% were male. We identified an inverse correlation between EQ-5D VAS and EQ-5D domains with the highest for mobility (rs = -0.69) and the lowest for pain/discomfort (rs -0.52, p<0.001). The r2 ranged from 0.25 (pain/discomfort) to 0.47 (EQ-5D index). Patients with mRS ≥ 3 significantly reduced their EQ-5D VAS score by 25.64 points (95% CI -33.04, -18.24). Variability in EQ-5D VAS scores occurred by EQ-5D index (47%) and by mRS (34%). Conclusions: The correlation between EQ-5D and mRS was favorable. Although EQ-5D and mRS evaluated different spheres on stroke patients, applying the EQ-5D instrument in real-world clinical settings might contribute multidimensional information on how life is affected after a stroke. This kind of information serves to orientate rehabilitation strategies on specific domains such as depression, self-care, anxiety, and pain. This is especially relevant for patients with disabilities (mRS ≥ 3).

Introducción: La evaluación de la Calidad de Vida Relacionada con la Salud (CVRS) y el estado funcional de pacientes con Ataque Cerebrovascular (ACV), podría complementar la práctica clínica. Objetivo: Evaluar la CVRS, aplicando EuroQol-5-dimensiones (EQ-5D) en pacientes colombianos con ACV y correlacionar sus resultados con la escala de Rankin Modificada (mRS). Métodos: Estudio de corte transversal analítico anidado a una cohorte de pacientes con ACV isquémico en Colombia con mediana de 3 meses de seguimiento (Q1: 1- Q3:3) post-ictus. Correlacionamos los dominios del EQ-5D, índice EQ-5D y mRS con la puntuación de EQ-5D VAS. Generamos un modelo de regresión lineal simple para evaluar la variabilidad usando r2. Resultados: Un total de 91 pacientes con una edad media 71,2 años; 59,3 % hombres. Se encontró correlación inversa entre los dominios EQ-5D, mayor para movilidad (rs = -0,69) y menor para dolor/malestar (rs -0,52, p < 0,001). El r2 osciló entre 0,25 (dolor/malestar) y 0,47 (índice EQ-5D). Los pacientes con mRS ≥ 3 redujeron significativamente su puntuación EQ-5D VAS en 25,64 puntos (IC 95%: -33,04; -18,24). La variabilidad en las puntuaciones EQ-5D VAS se produjo por el índice EQ-5D (47 %) y por mRS (34 %). Conclusiones: La correlación entre EQ-5D y mRS fue favorable. Aunque EQ-5D y mRS evalúan diferentes esferas en los pacientes con ACV, la aplicación del EQ-5D en podría aportar información multidimensional sobre cómo se afecta la vida después de un ictus, así como orientar estrategias de rehabilitación en esferas como depresión, autocuidado, ansiedad y dolor; especialmente relevante para pacientes con discapacidades (mRS ≥ 3).

Adhesive Capsulitis' Patients Report Improvement in Functionality Trough International Classification of Functioning, Disability and Health Checklist and Dash After Suprascapular Nerve Blocks / Pacientes com capsulite adesiva relatam melhora da funcionalidade pela Classificação Internacional de Funcionalidade, Incapacidade e Saúde e DASH após bloqueios do nervo supraescapular

Abstract Objective To evaluate the functionality in patients with adhesive capsulitis undergoing suprascapular nerve block (SSNB). Methods A before-and-after clinical prospective study in a single center was conducted with patients with secondary adhesive capsulitis treated with four nerve blocks based on anatomical limits. The sample was non-probabilistic, and it was obtained after a routine appointment at a specialized outpatient clinic. The instruments used for evaluation were the International Classification of Functioning, Disability and Health (ICF) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, which were applied at baseline (T0), one week after the fourth SSNB (T4), and three months after the first SSNB (T12). The paired t-test was used to compare the means of the ICF checklist items and DASH in the different: T0xT4;T4xT12;and T0xT12). The probability of rejecting the null hypothesis was 5%. Results The sample was composed of 25 individuals with a mean age of 58.16 years; 16 of them were female. The duration of the pain symptoms ranged from 2 to 16 months, with a mean of 5.92 months. The ICF checklist showed that all domains had already improved in T4 except for the environmental factors, which only improved at 03 months (p = 0.037). The patients reported improvements in shoulder function in T4, which increased more in T12, at the end of data collection (p = 0.019). Conclusion The SSNB technique is effective in patients with adhesive capsulitis after4 weeks of application, with improvements in individual's functionality lasting for 12 weeks.

Resumo Objetivo Avaliar a funcionalidade em pacientes com capsulite adesiva submetidos a bloqueio do nervo supraescapular (BNSE). Métodos Um estudo clínico prospectivo do tipo antes e depois foi realizado em um único centro com pacientes com capsulite adesiva secundária tratados com quatro bloqueios baseados em limites anatômicos. A amostra foi não probabilística, tendo sido obtida após consulta de rotina em ambulatório especializado. Os instrumentos utilizados para avaliação foram a Classificação Internacional de Funcionalidade, Incapacidade e Saúde (CIF) e o questionário de Disfunções do Braço, Ombro e Mão (DASH), que foram aplicados antes da intervenção (T0), uma semana após o quarto BNSE (T4),etrêsapósoprimeiroBNSE(T12).AsmédiasdositensdaCIFedoDASHnos diferentes tempos (T0 x T4; T4 x T12; e T0 x T12) foram comparadas por meio do teste t pareado. A probabilidade de rejeitar a hipótese nula foi de 5%. Resultados A amostra foi composta por 25 indivíduos com média de idade de 58,16 anos; 16 eram mulheres. A duração dos sintomas dolorosos variou de 2 a 16 meses, com média de 5,92 meses. A CIF mostrou que todos os domínios já haviam melhorado em T4 à exceção dos fatores ambientais, que só melhoraram aos 3 meses (p = 0,037). Os pacientes já relataram melhora na função do ombro em T4 emaisainda em T12,ao finaldacoletadedados (p = 0,019). Conclusão A técnica de BNSE é eficaz em pacientes com capsulite adesiva após 4 semanas de aplicação, com melhora da funcionalidade do indivíduo e sua manutenção até 12 semanas.

Instrumentos de avaliação sobre qualidade de vida em adultos estomizados: protocolo de revisão sistemática / Instruments to assess quality of life in ostomized adults: a systematic review protocol

OBJETIVO: Analisar metodologicamente resultados de pesquisas que investigaram as propriedades psicométricas(confiabilidade, responsividade e validade) de instrumentos de qualidade de vida para pessoas com estomias de eliminação. MÉTODO: Revisão sistemática da literatura que será realizada de acordo com a iniciativa Consensus-based Standards for the selection oh health Measurement INstruments (COSMIN), desenvolvida em dez etapas. As buscas serão realizadas em bases de dados nacionais e internacionais, sem restrição de idiomas e temporal. Para avaliar a qualidade metodológica dos estudos, empregar-se-á o checklist de risco de viés COSMIN, aplicando-se os critérios de qualidade para boas propriedades de medida. Por último, as evidências serão compiladas, avaliando-se sua qualidade através da abordagem GRADE. Este estudo encontra-se em andamento e o protocolo está registrado na International Prospective Register of Systematic Reviews (PROSPERO) sob o número CRD42022320642

OBJECTIVE: To methodologically analyze the results of research studies that investigated psychometric properties (reliability, responsiveness and validity) of quality of life instruments for individuals with elimination ostomies. METHOD: A systematic literature review that will be conducted according to the Consensus-based Standards for selecting health Measurement Instruments (COSMIN) initiative, developed in ten stages. The searches will be conducted in national and international databases, with no language or time restrictions. To assess the methodological quality of the studies, the COSMIN risk of bias checklist will be employed by applying the quality criteria for good measuring properties. Finally, the diverse evidence will be compiled by assessing its quality through the GRADE approach. This study is ongoing and its protocol is registered at the International Prospective Register of Systematic Reviews (PROSPERO) under number CRD42022320642

Quality of life: predictors and outcomes after stroke in a Brazilian public hospital / Qualidade de vida: preditores e desfechos após acidente vascular cerebral em um hospital público brasileiro

Abstract Background Some scales are applied after stroke to measure functional independence but qualify of life (QoL) is sometimes neglected in this scenario. Objective To analyze predictors and outcomes of QoL after stroke using a validated scale in our population. Methods Our study included patients who had their first ischemic stroke and were followed in the outpatient clinic for at least 6 months from stroke index. Disability status was assessed using the modified Rankin scale (mRS), the Barthel index (BI), and the Lawton and Brody scale. Quality of life was assessed by a stroke-specific QoL (SSQoL) scale. Statistical significance was accepted for p< 0.05. The estimated measure of association was the odds ratio (OR) for which 95% confidence intervals (95%Cis) were presented. Results Of 196 patients studied, the median age was 60.4 (±13.4) years, and 89 (45.40%) of the patients were female. In a stepwise model considering risk factors, basic activities of daily living scales, satisfaction with life, and outcomes, we found four independent variables related to a poor QoL after stroke, namely hypertension, non-regular rehabilitation, not returning to work, and medical complications. The National Institutes of Health stroke scale (NIHSS) score at admission ≥ 9 was also an independent clinical marker. Approximately 30% of all participants had a negative score under 147 points in the SSQoL. Conclusions Our results showed that QoL after stroke in a developing country did not seem to differ from those of other countries, although there is a gap in rehabilitation programs in our public system. The functional scales are important tools, but they have failed to predict QoL, in some patients, when compared with specific scales.

Resumo Antecedentes Algumas escalas são aplicadas após o acidente vascular cerebral (AVC) para avaliar a independência funcional, mas a qualidade de vida (QV) às vezes é negligenciada nesse cenário. Objetivo Analisar preditores e desfechos de QV após AVC utilizando uma escala validada em nossa população. Métodos Nosso estudo incluiu pacientes que tiveram seu primeiro AVC isquêmico e foram acompanhados no ambulatório por pelo menos 6 meses após o AVC. A funcionalidade foi avaliada pela escala de Rankin modificada, índice de Barthel e escala de Lawton e Brody. A QV foi avaliada pela ecala de qualidade de vida específica de acidente vascular cerebral (SSQoL). A significância estatística aceita foi p< 0,05. A medida de associação estimada foi o odds ratio (OR), para o qual foram apresentados intervalos de confiança (IC) de 95%. Resultados Dos 196 pacientes, a média de idade foi de 60,4 (±13,4) anos, sendo 89 (45,40%) do sexo feminino. Em um modelo stepwise considerando fatores de risco, escalas de atividades básicas da vida diária, satisfação com a vida e desfechos, encontramos quatro variáveis independentes relacionadas a uma QV ruim após o AVC, como hipertensão, reabilitação não regular, não retorno ao trabalho e comorbidades pós-AVC. A pontuação NIHSS na admissão ≥ 9 também foi um marcador clínico independente. Aproximadamente 30% de todos os participantes tiveram uma pontuação abaixo de 147 pontos para SSQoL. Conclusões Nossos resultados mostraram que a QV após AVC em um país em desenvolvimento não parece diferir de outros países, apesar da lacuna nos programas de reabilitação em nosso sistema público. As escalas funcionais são ferramentas importantes, mas falharam em alguns pacientes em predizer a QV quando comparadas com escalas específicas.

Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial / Eficácia da fixação sacroespinhal ou da suspensão do ligamento útero-sacro no prolapso de órgãos pélvicos nos estágios III e IV: Ensaio clínico randomizado

Abstract Objective To evaluate the efficacy and outcomes of the surgical treatment for pelvic organ prolapse (POP) in stages III and IV by sacrospinous ligament fixation (SSLF) or uterosacral ligament suspension (USLS) by comparing anatomical and subjective cure rates and quality-of-life parameters (through the version validated for the Portuguese language of the Prolapse Quality of Life [P-QoL] questionnaire) under two definitions: genital prolapse Ba, Bp, and C< −1 (stage I) and Ba, Bp, and C ≤ 0 (stage II). Materials and Methods After we obtained approval from the Ethics Committee (under CAAE 0833/06) and registered the study in ClinicalTrials.gov (NCT 01347021), 51 patients were randomized into two groups: the USLS group (N = 26) and the SSLF group (N = 25), with follow-up 6 and 12 months after the procedures. Results There was a significant improvement in the P-QoL score and anatomical measurements of all compartments in both groups after 12 months (p< 0.001). The anatomical cure rates in the USLS and SSLF groups, considering stage 1, were of 34.6% and 40% (anterior) respectively; of 100% both for groups (apical); and of 73.1% and 92% (posterior) respectively. The rates of adverse outcomes were of 42% (N = 11) and 36% (N = 11) for the USLS and SSLF groups respectively (p= 0.654), and those outcomes were excessive bleeding, bladder perforation (intraoperative) or gluteal pain, and urinary infection (postoperative), among others, without differences between the groups. Conclusion High cure rates in all compartments were observed according to the anatomical criterion (stage I), without differences in P-QoL scores and complications either with USLS or SSLF for the surgical treatment of accentuated POP.

Resumo Objetivo Avaliar a eficácia e os resultados do tratamento cirúrgico para prolapso de órgãos pélvicos (POP) nos estágios III e IV, por meio da técnica de fixação do ligamento sacroespinal (FLSE) ou suspensão do ligamento útero-sacro (SLUS), ao comparar os índices de cura anatômicos, subjetivos, e os parâmetros de qualidade de vida (por meio do questionário Prolapse Quality of Life [P-QoL] validado para a língua portuguesa) sob duas definições: prolapso genital Ba, Bp e C< −1 (estágio I) e Ba, Bp e C ≤ 0 (estágio II). Materiais e Métodos Após aprovação do Comitê de Ética (CAAE 0833/06) e registro no ClinicalTrials.gov (NCT 01347021), 51 pacientes foram randomizadas em dois grupos: grupo SLUS (N = 26) e (2) grupo FLSE (N = 25), com seguimento de 6 e 12 meses. Resultados Houve melhora significativa nas pontuações no P-QoL e nas medidas anatômicas de todos os compartimentos em ambos os grupos após 12 meses (p< 0,001). As taxas de cura anatômica nos grupos SLUS e FLSE , considerando o estágio 1, foram de 34,6% e 40% (anterior), respectivamente; de 100% em ambos os grupos (apical); e de 73,1% e 92% (posterior), respectivamente. As taxas de resultados adversos foram de 42% (N = 11) e 36% (N = 11), respectivamente, nos grupos SLUS e FLSE (p= 0,654), e elas foram sangramento excessivo, perfuração da bexiga (intraoperatória) ou dor glútea, e infecção urinária (pós-operatória), entre outras, sem diferenças entre os grupos. Conclusão Altas taxas de cura em todos os compartimentos foram observadas segundo critério anatômico (estágio I), sem diferença quanto às pontuações no P-QoL e às complicações tanto com SLUS quanto com FLSE para o tratamento cirúrgico de POP acentuado.

Hipersensibilidade dentinária e satisfação com a saúde mediada pela presença de impacto físico e psicossocial das condições bucais: uma análise de caminhos / Dentin hypersensitivity and health satisfaction mediated by the presence of physical and psychosocial impacts of oral conditions: a pathway analysis

Objetivo: Objetivou-se investigar associação direta e mediada pela presença de impacto físico e psicossocial das condições bucais entre HD e satisfação com a saúde entre adultos. Métodos: Estudo transversal foi realizado entre 2018-2019 com amostra probabilística por conglomerado de adultos residentes em Rio Acima (MG). Entrevista e exame bucal foram realizados por examinadoras calibradas. Satisfação com a saúde foi avaliada por meio da pergunta doWHOQoL-bref "Quão satisfeito (a) você está com a sua saúde?" e suas respostas categorizadas entre "satisfeito" e "insatisfeito". HD foi avaliada por estímulo tátil na região cervical dos dentes. Presença de impactos físicos e psicossociais das condições bucais foi definida pelas respostas "repetidamente" ou "sempre" a pelo menos um dos itens do OHIP-14. Covariáveis foram dados sociodemográficos e econômicos, comportamentos em saúde, condições de saúde bucal e uso de serviços odontológicos. Associações foram investigadas por modelos de Regressão de Poisson e Modelagem de Equações Estruturais (MEE) para estimar associações diretas e indiretas (Stata 16). Resultados: Dos 197 adultos, 132 (66,18%) declararam estar satisfeitos com sua saúde e 73 indivíduos (38,75%) apresentavam HD. Houve associação significativa entre presença de HD e presença de impacto físico e psicossocial das condições bucais (RP: 1.34; IC 95%: 1.08­1.67), enquanto para satisfação a associação com HD não foi significativa (RP: 1.08; IC 95%: 0.75-1.54) após a inclusão da variável presença de impacto físico e psicossocial das condições bucais. MEE demonstrou associação direta não significativa entre HD e satisfação, enquanto a associação indireta mediada pela presença de impacto físico e psicossocial das condições bucais foi significativa. Conclusão: Indivíduos com HD podem relatar maior insatisfação com a vida quando esta experiência dolorosa está associada com impactos físicos ou psicossociais.

Aim: Dentin Hypersensitivity (DH) is a painful condition that affects the Oral Health-related Quality of Life and can affect the satisfaction with health of individuals who have it. This study aimed to investigate the direct association mediated by the presence of physical and psychosocial impacts of oral conditions between DH and satisfaction with health among adults. Methods: A cross-sectional study was carried out between 2018-2019 with a probabilistic sample consisting of a cluster of adults living in Rio Acima (MG). Interviews and epidemiological examinations were performed using calibrated tests. The dependent variable of satisfaction with health was assessed using the WHOQoL-bref question "How satisfied are you with your health?" Participants' answers were categorized between "satisfied" and "dissatisfied". The independent DH variable was assessed by tactile stimulation in the cervical region of the teeth. The presence of physical and psychosocial impacts of oral conditions was defined by the answers "farly often" or "very often" to at least one of the OHIP-14 items. Covariates were sociodemographic and psychological data, health behavior, oral health conditions, and use of dental services. Associations were investigated by Poisson Regression and Structural Equation Modeling (SEM) models to estimate direct and indirect associations (Stata 16). Results: Of the 197 adults, 132 (66.18%) reported being satisfied with their health, and 73 individuals (38.75%) had DH. There was a significant association between the presence of DH and the presence of physical and psychosocial impacts of oral health (PR:1.34; 95% CI: 1.08­1.67), while for receiving the association with DH, it was not significant (PR:1 .08; 95% CI: 0.75-1.54) after including the presence of impact variables. SEM showed a non-significant direct association between DH and satisfaction, while the indirect association mediated by the presence of impact was significant. Conclusion: Individuals with HD may report greater dissatisfaction with life when this painful experience is associated with physical or psychosocial effects.

Association between Dentin Hypersensitivity and Health/Oral Health-related Quality of Life: A Systematic Review and Meta-Analysis

ABSTRACT Objective: To investigate the association between DH and Health (HRQoL) or Oral Health-Related Quality of Life (OHRQoL). Material and Methods: PubMed, Web of Science, Scopus, EMBASE, Cochrane, Scielo, LILACS/BBO, Biblioteca Digital de Teses e Dissertações (BDTD), Open Grey, and Google Scholar databases were screened in September 2019 (updated in October 2022). Observational studies were selected to compare HRQoL/OHRQoL(outcome) according to DH(exposure) or evaluate the association among these variables. Standardized Joanna Briggs Institute critical appraisal tool for analytical cross-sectional studies was used to analyze the risk of bias. A random-effects meta-analysis was conducted to synthesize evidence for the association between DH and OHRQoL. Results: 10 papers met inclusion criteria and were evaluated. In most studies, presenting or having a greater intensity of DH was associated with a negative impact on one's quality of life. However, most of these studies showed a moderate to high risk of methodological bias. The consistent finding from studies with a low risk of bias suggests a significant association between DH and OHRQoL. Meta-analysis was feasible for three studies with substantial heterogeneity. The pooled Odds Ratio was 2.14 (95%CI 1.15-3.99; I2= 57,44%). Conclusion: Many studies presented a high risk of bias; therefore, the actual effect of DH on one's quality of life remains uncertain.

Research Progress in Application of Patient-Reported Outcome Measures in Total Knee Arthroplasty / 中国医学科学院学报

To summarize the clinical application of patient-reported outcome measures (PROM) in total knee arthroplasty (TKA) and provide reference for the application of PROM in perioperative evaluation of the patients receiving TKA,we reviewed the recent studies about the application of PROM in TKA and analyzed the contents and application characteristics of the PROM.The common PROM in TKA,such as the Western Ontario and McMaster Universities Osteoarthritis Index,Oxford Knee Score,and Forgotten Joint Score,principally focus on patients' subjective feelings about pain,function and other aspects of their knees.However,they have diverse ranges of application and each of them has their own advantages and disadvantages.There is a variety of PROM applied in TKA,which makes it challenging to select the proper measurement for evaluation.The PROM in TKA remains to be improved for broader use.

Patient-reported outcome measures and value-based medicine in paediatrics: a timely review

Healthcare delivery is moving towards a more personalised and patient-centric approach. There is now an appropriate emphasis on providing value in our healthcare system. Patient-reported outcome measures (PROMs) assess our patients' perceptions of the status of their health and quality of life, measured over a period of time. PROM is an integral component of a value-driven and value-based healthcare system and is key if we want to practise value-based medicine. In paediatrics and child health, PROMs, if implemented well with appropriate measurement tools that are regularly updated and validated in a self-learning healthcare ecosystem, will help to enhance personalised healthcare delivery and collectively improve the health of the community at large. This review covers the role of PROMs in paediatrics, as well as their role in value-based medicine.

Research progress on patient-reported outcomes in foot and ankle surgery / 中华骨科杂志

Patient-reported outcomes (PROs) are information that comes directly from any aspect of a patient's own health status. The traditional patient-reported outcome measures (PROMs) used in foot and ankle surgery include the American Association of Foot and Ankle Surgery series scale, the visual analogue scale, the medical outcomes study 36-item short form of health survey (SF-36), the foot and ankle outcome scale and the medical outcome study 12-item short form of health survey (SF-12). In the process of use, these PROMs can not accurately reflect the patient's feelings because of the subjective influence of doctors, only responding to specific diseases or general health conditions, and the test fatigue caused by too long questionnaires, which ultimately affect the reliability and validity of the results. The scales of the patient-reported outcome measurement information system (PROMIS) led by National Institutes of Health have been verified to have good reliability, validity and responsiveness, and its results are true and reliable, and have high clinical reference significance. The PROMIS includes short forms, short form collection and computerized adaptive test (CAT), of which the PROMIS CAT is built on scientific item response theory, with the selection of each question highly correlated with the underlying trait of the patient, and the accuracy and credibility of PROs significantly improved. The PROMIS score has been applied in clinical practice in foot and ankle surgery (including hallux valgus, flatfoot and talar neck fractures, etc.) and has demonstrated excellent and stable preoperative prediction and prognosis evaluation ability. The presentation of PROMIS and its application progress can enhance the participation of patients of foot and ankle surgery in medical activities and guide clinical decision-making in foot and ankle surgery.

Clinical Outcome Measures in Arthroscopic Meniscectomy: Clinician versus Patient Completed Knee Scores / Medidas de desfechos clínicos na meniscectomia artroscópica: Pontuações de joelho segundo médicos e pacientes

Abstract Objective The aim of the present study was to investigate the difference between clinician-completed and patient-completed outcome scores in detecting improvement following arthroscopic meniscectomy in patients with meniscal tears of the knee. Methods Thirty-four patients with meniscal tears were prospectively assessed using 9 clinical outcome measures. The five clinician-completed knee scores included the Tegner Activity Score, the Lysholm Knee Score, the Cincinnati Knee Score, the International Knee Documentation Committee (IKDC) Examination Knee Score, and the Tapper and Hoover Meniscal Grading Score. The four patient-completed knee scores included the IKDC Subjective Knee Score, the Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADLS), the Short Form-12 Item Health Survey (SF-12), and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Twenty-nine of the 34 patients underwent an arthroscopic meniscectomy and were reassessed with all 9 outcome scores upon their follow-up review. Results A significant longitudinal improvement was observed in 4 of the 5 clinician-completed scores (Tegner [p< 0.001], Lysholm [p= 0.004], Cincinnati [p = 0.002] and Tapper and Hoover [p< 0.001], but not in the IKDC Examination [p= 0.332]. However, the IKDC Subjective score (p= 0.021) was the only patient-completed score to demonstrate significant improvement postoperatively. Conclusion Overall, clinician-completed scoring systems were found to be inconsistent with those of patient-completed instruments. The mode of administering outcome measures can have a significant influence on the outcome results both for research and for clinical practice. A combination of both a clinician-completed with a patient-completed instrument may be a more balanced approach to assessing and quantifying meniscus tears and the outcome following arthroscopic meniscectomy.

Resumo Objetivo O objetivo do presente estudo foi investigar a diferença entre instrumentos de desfechos preenchidos por médicos e pacientes na detecção de melhora após a meniscectomia artroscópica para tratamento de rupturas de menisco. Métodos Trinta e quatro pacientes com rupturas de menisco foram avaliados de forma prospectiva usando 9 medidas de desfechos clínicos. Os cinco instrumentos de avaliação de joelho respondidos por médicos foram o Escore de Atividade de Tegner, o Escore de Joelho de Lysholm, o Escore de Joelho de Cincinnati, o Escore de Exame do Joelho do International Knee Documentation Committee (IKDC, na sigla em inglês) e o Escore de Classificação do Menisco de Tapper e Hoover. Os quatro instrumentos de avaliação do joelho respondidos por pacientes foram o Escore Subjetivo do Joelho do IKDC, a Pesquisa de Desfecho de Joelho - Escala de Atividades de Vida Diária (KOS-ADLS, na sigla em inglês), o Formulário Curto de Pesquisa em Saúde de 12 Itens (SF-12, na sigla em inglês) e o Escore de Desfecho de Osteoartrite e Lesões no Joelho (KOOS, na sigla em inglês). Vinte e nove dos 34 pacientes foram submetidos a uma meniscectomia artroscópica e reavaliados com todos os 9 instrumentos na sua consulta de acompanhamento. Resultados Uma melhora longitudinal significativa foi observada em 4 dos 5 instrumentos respondidos por médicos (Tegner [p< 0,001], Lysholm [p= 0,004], Cincinnati [p= 0,002] e Tapper e Hoover [p< 0,001], mas não no IKDC [p= 0,332]). Por outro lado, o Escore Subjetivo do Joelho do IKDC (p= 0,021) foi o único instrumento respondido por pacientes a demonstrar melhora pós-operatória significativa. Conclusão De modo geral, os instrumentos respondidos por médicos foram considerados inconsistentes em relação àqueles respondidos por pacientes. O modo de administração dos instrumentos pode ter influência significativa nos resultados, tanto para fins de pesquisa quanto para a prática clínica. A combinação de um instrumento respondido pelo médico com um instrumento respondido pelo paciente pode ser uma abordagem mais equilibrada para a avaliação e a quantificação das rupturas do menisco e do desfecho após a meniscectomia artroscópica.

Development of a Patient Registry System for Specialized Palliative Care Quality Assessment Using Patient-reported Outcomes: A Multicenter Pilot Study

Objective: This study aimed to investigate the feasibility of a patient registry system for assessing PCT (palliative care team) by PRO (Patient-reported outcome) in Japan. Methods: We operated a patient registry system with electronic data collection at eight hospitals in 2021 in Japan. We consecutively included newly referred patients for a month and followed up with them for a month. IPOS or ESAS obtained as PRO at the start of the intervention, three days later, and every week after. The primary endpoint was the response rate to the symptom rating scale by patients and providers. Results: 318 patients were enrolled. The patient response rate was 59.1% at intervention and 37.0% after intervention, and the medical provider response rate was 98.4% at intervention and 70.3% after intervention. Interviews with PCT members indicated that participants required support to input PRO responses required support and paper questionnaire was better and that managing the survey date and overall management was burdensome. Discussion: Although only about half of the patients were able to respond to the PRO, this was the same level as in previous studies. The system and its operation method have many problems. We found that improvements such as reducing items and making the patient interviews paper-based are necessary to expand the system nationwide.

Linguistic validation and psychometric testing of the Filipino version of the Breast-Q Reconstruction Module

Background@#The introduction of new therapeutic options and advances in the field of breast surgery has put the importance of patient satisfaction and quality of life at par with long-term survival. These essential parameters help physicians and patients decide on the appropriate approach when managing both malignant and benign breast conditions. They have also been used to measure the outcome and success of breast surgery, whether cosmetic or reconstructive, using patients’ perspectives. To date, there is no available questionnaire that is translated, culturally adapted, and validated among Filipino patients to specifically assess their quality of life (QOL) and satisfaction after breast reconstructive surgery.@*Objective@#This study aims to translate a previously validated, internationally accepted, patient-reported outcome (PRO) instrument, the Breast-Q Reconstruction Module, and validate its use among Filipino patients. @*Methods@#This is a tool validation study of a Filipino translation of the Breast-Q Reconstruction Module for the preoperative and postoperative settings. Forward and backward translations were done for the two questionnaires and were finalized after assessment of accuracy and feasibility by language professionals and bilingual patients. We recruited patients referred to the Division of Plastic Surgery of a tertiary government hospital for breast reconstruction to answer the final questionnaires, with 15 re-taking each questionnaire after two weeks. Psychometric properties of the questionnaires, including internal consistency, construct validity, test-retest reliability, and acceptability, were then evaluated. @*Results@#We included 30 patients in this validation study. The internal consistencies of the translated Preoperative and Postoperative Breast-Q Reconstruction Module had high Cronbach’s α coefficients (range: 0.92–0.98 and 0.97–1.00, respectively). Internal consistency was also supported by high mean item-total correlations in all dimensions. The two questionnaires had good test-retest reliability as supported by high intraclass correlation (range for Preoperative: 0.995–1.000 and for Postoperative: 0.95–1.00). Construct validity was supported by inter-scale correlations with low to moderate Spearman’s coefficients (range for Preoperative: 0.22–0.34 and for Postoperative: 0.11–0.27). The sexual well-being dimension had the lowest inter-scale Spearman’s coefficient in both questionnaires and is the only dimension with low acceptability. @*Conclusion@#The translated Preoperative and Postoperative Breast-Q Reconstruction Module has high internal consistency, test-retest reliability, acceptability, and low to moderate construct validity among Filipino patients after breast reconstruction surgery. However, the “Satisfaction with the Nipple Reconstruction” subscale is pending since there were no qualified respondents in the sample population. In considering how their relatively conservative culture influences the way Filipino patients tend to view the importance of sexual satisfaction as it relates to their medical management, the sexual well-being domain is suggested to be interpreted separately when assessing the patient’s overall satisfaction with breast reconstruction procedure.

Quality of life analysis after Whipple procedure. Retrospective cohort study / Análisis de calidad de vida en cirugía Whipple. Estudio de cohorte retrospectiva

Abstract Introduction Patient reported outcomes establish the patient's own perception about his/her health and enable the development of policies designed to improve health/disease processes. These are particularly helpful in the case of diseases with a significant impact on the patient's quality of life. Objective To compare the quality of life scores assessed using the EQ-5D-5L questionnaire in patients undergoing cephalic duodenopancreatectomy (Whipple procedure) and laparoscopic cholecystectomies in the same hospital. Methodology Retrospective cohort trial between July 2018 and February 2020. Patients programmed for cephalic duodenopancreatectomy were included, regardless of the type of pathology, and over 18 years old. Patients with carcinomatosis or vascular infiltration were excluded. The EQ-5D-5L was administered following Whipple surgery and compared against a control group (laparoscopic cholecystectomy). The demographic characteristics, the diagnosis, hospital stay and 60-day mortality were assessed. Results A total of 68 patients were included. The most frequent diagnosis was pancreatic cancer (30 %) in the Whipple group and lithiasis (100 %) in the control group. In the five dimensions assessed, there were no differences in terms of mobility (OR: 0.41, 95 % CI [0.30-0.57], p = 0.103) and in terms of personal care (OR: 0.42, 95 % CI [0.32-0.58], p = 0.254). There was a difference in daily life activities (OR: 0.38, 95 % CI [0.27-0.54], p = 0.017), pain/malaise (OR: 2.33, 95 % CI [0.99-5.48]), p = 0.013 and anxiety/depression (OR: 0.39, 95 % CI [0.28-0.55], p = 0.019). The overall health perception was 80 points for Whipple (IQR 60-90) vs. 100 points for the control group (IQR 90-100). Conclusions Patients undergoing a Whipple procedure experience a health perception slightly lower than patients undergoing laparoscopic cholecystectomy. This difference may be associated with increased pain, anxiety/depression and a reduction in their activities of daily life. The administration of the EQ-5D-5L questionnaire to measure quality of life is a friendly tool that used be used routinely to plan activities aimed at improving medical care.

Resumen Introducción Los desenlaces informados por el paciente permiten establecer cuál es la percepción que tiene de su salud y crear políticas que mejoren procesos en salud/enfermedad. Son particularmente útiles en enfermedad que afectan la calidad de vida de forma importante. Objetivo Comparar las puntuaciones de calidad de vida evaluadas mediante el cuestionario EQ-5D-5L en pacientes sometidos a duodenopancreatectomía cefálica (procedimiento de Whipple) y colecistectomías laparoscópicas en el mismo centro hospitalario. Metodología Estudio de cohorte retrospectivo entre julio de 2018 y febrero de 2020. Se incluyeron pacientes programados para duodenopancreatectomía cefálica independientemente del tipo de patología y mayor de 18 años de edad; se excluyeron pacientes con carcinomatosis o infiltración vascular. Se aplicó el cuestionario EQ-5D-5L después de cirugía Whipple y se comparó con un grupo control (colecistectomía laparoscópica). Se evaluaron características demográficas, diagnóstico, estancia hospitalaria y mortalidad a 60 días. Resultados Se incluyeron 68 pacientes. El diagnóstico más frecuente fue cáncer de páncreas (30 %) en el grupo Whipple y litiasis (100 %) en el grupo control. En las 5 dimensiones evaluadas no hubo diferencias en movilidad (OR: 0,41, IC 95 % [0,30-0,57], p = 0,103) y en cuidado personal (OR: 0,42, IC 95 % [0,32-0,58], p = 0,254). Se encontró diferencia en actividades cotidianas (OR: 0,38, IC 95 % [0,270,54], p = 0,017), dolor/malestar (OR: 2,33, IC 95 % [0,99-5,48]), p = 0,013 y angustia/depresión (OR: 0,39, IC 95 % [0,28-0,55], p = 0,019). La percepción general de salud fue 80 puntos para Whipple (RIQ60-90) vs. 100 puntos para el grupo control (RIC 90-100). Conclusiones Los pacientes sometidos a Whipple presentan una percepción de salud ligeramente menor que los pacientes de colecistectomía laparoscópica. Esta diferencia puede estar relacionada con el aumento en dolor, angustia/depresión y disminución en actividades cotidianas. La aplicación del cuestionario EQ-5D-5L para medición de calidad de vida es una herramienta fácil de aplicar que debería realizarse rutinariamente para planear intervenciones dirigidas a mejorar la atención médica.

Functional outcomes of arthroscopic treatment in 230 femoroacetabular impingement cases / Functional result of arthroscopic treatment in 230 impacts femoroacetabulares

ABSTRACT Objective: To analyze the functional outcomes after arthroscopic treatment of femoroacetabular impingement (FAI). Methods: 194 patients (131 males and 63 females), with a mean age of 39 (15-68) years old for men and 43 (16-58) years old for women. The average follow-up was 17 months (2 to 71). 103 patients presented Cam-type FAI, 102 mixed and 25 Pincer. "Unilateral" arthroscopy was performed in 161 cases, "Bilateral" (only once each side) in 46 cases and, "Multiple" (more than one procedure on the same hip) in 23. The female sex was prevalent in the Pincer type FAI (76%), while males were prevalent in Mixed and Cam type, 74.5% and 72.8%, respectively. Results: The mean HHSpre score was 63.7 and 87.1 for HHSpost, i.e. 73.11%. Differences appeared between "mixed" and "unilateral" groups. The complications percentage in this series was 18.7% and 7% progressed to total hip arthroplasty. Conclusion: The arthroscopic FAI treatment improved the postoperative clinical scores of these patients, especially in cases of mixed-type FAI, which presented a higher improvement rate. Insufficient femoral osteoplasty was the main cause for surgical re-intervention, particularly in the initial cases of this series. Level of Evidence II, Retrospective study.

RESUMO Objetivo: Avaliar os resultados funcionais após tratamento artroscópico do impacto femoroacetabular (IFA). Métodos: Foram selecionados 194 pacientes (131 do sexo masculino e 63 do sexo feminino), com idade média de 39 (15-68) anos no caso dos homens e 43 (16-58) anos para as mulheres. O seguimento médio foi de 17 meses (2 a 71). 103 pacientes apresentaram IFA tipo Came, 102 Misto e 25 tipo Pincer. A artroscopia única foi realizada em 161 casos; a bilateral (somente uma vez cada lado) em 46 casos e a múltipla (mais de um procedimento no mesmo quadril) em 23. O sexo feminino foi prevalente no IFA do tipo Pincer (76%) e o masculino nos tipos Misto e Came, 74,5% e 72,8%, respectivamente. Resultados: A média do escore HHSpré foi de 63,7 para HHSpós de 87,1, ou seja 73,11% Ficaram evidenciadas diferenças nos grupos "misto" e "único". O percentual de complicações desta série foi de 18,7% e 7% evoluíram para artroplastia total do quadril. Conclusão: O tratamento artroscópico IFA melhorou os escores clínicos, principalmente nos casos de IFA do tipo misto, que apresentou maior taxa de melhora, A osteoplastia femoral insuficiente foi a principal causa para reintervenção cirúrgica, particularmente nos casos iniciais desta série. Nível de Evidência II, Estudo retrospectivo.

Qualidade de vida e desfechos em longo prazo após hospitalização por COVID-19: Protocolo para um estudo de coorte prospectivo (Coalizão VII) / Quality of life and long-term outcomes after hospitalization for COVID-19: Protocol for a prospective cohort study (Coalition VII)

RESUMO Introdução: Os efeitos provocados pela COVID-19 em longo prazo são desconhecidos. O presente estudo tem como objetivo avaliar os fatores associados com a qualidade de vida relacionada à saúde e os desfechos em longo prazo em sobreviventes à hospitalização por COVID-19 no Brasil. Métodos: Este será um estudo multicêntrico de coorte prospectivo, aninhado em cinco ensaios clínicos randomizados desenhados para avaliar os efeitos dos tratamentos específicos para COVID-19 em mais de 50 centros no Brasil. Pacientes adultos sobreviventes à hospitalização por infecção por SARS-CoV-2 comprovada ou suspeita serão seguidos por um período de 1 ano, por meio de entrevistas telefônicas estruturadas. O desfecho primário é o escore de utilidade para qualidade de vida relacionada à saúde após 1 ano, avaliado segundo o questionário EuroQol-5D3L. Os desfechos secundários incluirão mortalidade por todas as causas, eventos cardiovasculares graves, reospitalizações, retorno ao trabalho ou estudo, condição funcional física avaliada pelo instrumento Lawton-Brody Instrumental Activities of Daily Living, dispneia avaliada segundo a escala de dispneia modificada do Medical Research Council, necessidade de suporte ventilatório em longo prazo, sintomas de ansiedade e depressão avaliados segundo a Hospital Anxiety and Depression Scale, sintomas de transtorno de estresse pós-traumático avaliados pela ferramenta Impact of Event Scale-Revised e autoavaliação da condição de saúde, conforme a Escala Visual Analógica do EuroQol-5D3L. Serão utilizadas equações de estimativas generalizada para testar a associação entre cinco conjuntos de variáveis (1 - características demográficas, 2 - condição de saúde pré-morbidade, 3 - características da doença aguda, 4 - terapias específicas para COVID-19 recebidas e 5 - variáveis pós-alta atualizadas) e desfechos. Ética e disseminação: O protocolo do estudo foi aprovado pelos Comitês de Ética em Pesquisa de todas as instituições participantes. Os resultados serão disseminados por meio de conferências e periódicos revisados por pares.

Abstract Introduction: The long-term effects caused by COVID-19 are unknown. The present study aims to assess factors associated with health-related quality of life and long-term outcomes among survivors of hospitalization for COVID-19 in Brazil. Methods: This is a multicenter prospective cohort study nested in five randomized clinical trials designed to assess the effects of specific COVID-19 treatments in over 50 centers in Brazil. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed-up for a period of 1 year by means of structured telephone interviews. The primary outcome is the 1-year utility score of health-related quality of life assessed by the EuroQol-5D3L. Secondary outcomes include all-cause mortality, major cardiovascular events, rehospitalizations, return to work or study, physical functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living, dyspnea assessed by the modified Medical Research Council dyspnea scale, need for long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-Revised, and self-rated health assessed by the EuroQol-5D3L Visual Analog Scale. Generalized estimated equations will be performed to test the association between five sets of variables (1- demographic characteristics, 2- premorbid state of health, 3- characteristics of acute illness, 4- specific COVID-19 treatments received, and 5- time-updated postdischarge variables) and outcomes. Ethics and dissemination: The study protocol was approved by the Research Ethics Committee of all participant institutions. The results will be disseminated through conferences and peer-reviewed journals.

Brazilian version of the Clinical COPD Questionnaire, administered by interview: reliability and validity measurement properties / Versão brasileira do Clinical COPD Questionnaire, aplicado por meio de entrevista: propriedades de medida de confiabilidade e validade

ABSTRACT Objective: To test the reliability, validity, and interpretability of the Brazilian version of the Clinical COPD Questionnaire (CCQ) in patients with COPD. Methods: Fifty patients with COPD completed the CCQ by interview on two occasions. At the first visit, the CCQ was administered twice, by two different raters, approximately 10 min apart; the patients also underwent spirometry and were administered the COPD Assessment Test, the modified Medical Research Council scale, and Saint George's Respiratory Questionnaire (SGRQ). At the second visit (1-2 weeks later), the CCQ was readministered. We tested the hypothesis that the CCQ total score would correlate positively with the total and domain SGRQ scores (r ≥ 0.5). Results: Of the 50 patients, 30 (60%) were male. The mean age was 66 ± 8 years, and the mean FEV1 was 44.7 ± 17.9% of the predicted value. For all CCQ items, Cronbach's alpha coefficient (95% CI) was 0.93 (0.91-0.96). To analyze the interrater reliability and test-retest reliability of the CCQ, we calculated the two-way mixed effects model/single measure type intraclass correlation coefficient (0.97 [95% CI: 0.95-0.98] and 0.92 [95% CI: 0.86-0.95], respectively); the agreement standard error of measurement (0.65 for both); the smallest detectable change at the individual level (1.81 and 1.80, respectively) and group level (0.26 and 0.25, respectively); and the limits of agreement (−0.58 to 0.82 and −1.14 to 1.33, respectively). The CCQ total score correlated positively with all SGRQ scores (r ≥ 0.70 for all). Conclusions: The Brazilian version of the CCQ showed an indeterminate measurement error, as well as satisfactory interrater/test-retest reliability and construct validity.

RESUMO Objetivo: Testar a confiabilidade, validade e interpretabilidade da versão brasileira do Clinical COPD Questionnaire (CCQ) em pacientes com DPOC. Métodos: Cinquenta pacientes com DPOC preencheram o CCQ por meio de entrevista em duas ocasiões. Na primeira visita, o CCQ foi aplicado duas vezes, por dois avaliadores, com intervalo de aproximadamente 10 min; os pacientes também foram submetidos a espirometria e aplicação do COPD Assessment Test, da escala modificada do Medical Research Council e do Saint George's Respiratory Questionnaire (SGRQ). Na segunda visita (1-2 semanas depois), o CCQ foi reaplicado. Testamos a hipótese de que a pontuação total no CCQ se correlacionaria positivamente com a pontuação total e a pontuação nos domínios do SGRQ (r ≥ 0,5). Resultados: Dos 50 pacientes, 30 (60%) eram do sexo masculino. A média de idade foi de 66 ± 8 anos, e a média do VEF1 foi de 44,7 ± 17,9% do valor previsto. Para todos os itens do CCQ, o coeficiente alfa de Cronbach (IC95%) foi de 0,93 (0,91-0,96). Para analisar a confiabilidade interavaliadores e teste-reteste do CCQ, calculamos o coeficiente de correlação intraclasse de duas vias modelo de efeitos mistos para medidas únicas (0,97 [IC95%: 0,95-0,98] e 0,92 [IC95%: 0,86-0,95], respectivamente); erro-padrão de medida do tipo concordância (0,65 para ambas); a mínima mudança detectável individual (1,81 e 1,80, respectivamente) e no grupo (0,26 e 0,25, respectivamente); e os limites de concordância (−0,58 a 0,82 e −1,14 a 1,33, respectivamente). A pontuação total no CCQ correlacionou-se positivamente com todas as pontuações no SGRQ (r ≥ 0,70 para todas). Conclusões: A versão brasileira do CCQ apresentou erro de medida indeterminado, assim como confiabilidade interavaliadores/teste-reteste e validade de construto satisfatórias.