How have research questions and methods used in clinical trials published in Clinical Rehabilitation changed over the last 30 years?

Research in rehabilitation has grown from a rare phenomenon to a mature science and clinical trials are now common. The purpose of this study is to estimate the extent to which questions posed and methods applied in clinical trials published in Clinical Rehabilitation have evolved over three decades with respect to accepted standards of scientific rigour. Studies were identified by journal, database, and hand searching for the years 1986 to 2016.A total of 390 articles whose titles suggested a clinical trial of an intervention, with or without randomization to form groups, were reviewed. Questions often still focused on methods to be used (57%) rather than what knowledge was to be gained. Less than half (43%) of the studies delineated between primary and secondary outcomes; multiple outcomes were common; and sample sizes were relatively small (mean 83, range 5 to 3312). Blinding of assessors was common (72%); blinding of study subjects was rare (19%). In less than one-third of studies was intention-to-treat analysis done correctly; power was reported in 43%. There is evidence of publication bias as 83% of studies reported either a between-group or a within-group effect. Over time, there was an increase in the use of parameter estimation rather than hypothesis testing and there was evidence that methodological rigour improved.Rehabilitation trialists are answering important questions about their interventions. Outcomes need to be more patient-centred and a measurement framework needs to be explicit. More advanced statistical methods are needed as interventions are complex. Suggestions for moving forward over the next decades are given.

Are the Items of the Starkstein Apathy Scale Fit for the Purpose of Measuring Apathy Post-stroke?

Importance: Given the importance of apathy for stroke, we felt it was time to scrutinize the psychometric properties of the commonly used Starkstein Apathy Scale (SAS) for this purpose. Objectives: The objectives were to: (i) estimate the extent to which the SAS items fit a hierarchical continuum of the Rasch Model; and (ii) estimate the strength of the relationships between the Rasch analyzed SAS and converging constructs related to stroke outcomes. Methods: Data was from a clinical trial of a community-based intervention targeting participation. A total of 857 SAS questionnaires were completed by 238 people with stroke from up to 5 time points. SAS has 14 items, rated on a 4-point scale with higher values indicating more apathy. Psychometric properties were tested using Rasch partial-credit model, correlation, and regression. Items were rescored so higher scores are interpreted as lower apathy levels. Results: Rasch analysis indicated that the response options were disordered for 8/14 items, pointing to unreliability in the interpretation of the response options; they were consequently reduced from 4 to 3. Only 9/14 items fit the Rasch model and therefore suitable for creating a total score. The new rSAS was deemed unidimensional (residual correlations: < 0.3), reasonably reliable (person separation index: 0.74), with item-locations uniform across time, age, sex, and education. However, 30% of scores were > 2 SD above the standardized mean but only 2/9 items covered this range (construct mistargeting). Apathy (rSAS/SAS) was correlated weakly with anxiety/depression and uncorrelated with physical capacity. Regression showed that the effect of apathy on participation and health perception was similar for rSAS/SAS versions: R2 participation measures ranged from 0.11 to 0.29; R2 for health perception was ∼0.25. When placed on the same scale (0-42), rSAS value was 6.5 units lower than SAS value with minimal floor/ceiling effects. Estimated change over time was identical (0.12 units/month) which was not substantial (1.44 units/year) but greater than expected assuming no change (t: 3.6 and 2.4). Conclusion: The retained items of the rSAS targeted domains of behaviors more than beliefs and results support the rSAS as a robust measure of apathy in people with chronic stroke.

The Effect of Pelvic Floor Muscle Contraction on Detrusor Overactivity Pressure in Neurogenic and Nonneurogenic Women During Urodynamic Study: A Cross-Sectional Study.

OBJECTIVE: The aims of this study were to investigate whether detrusor overactivity can be influenced by a pelvic floor muscle contraction in multiple sclerosis-associated overactive bladder and idiopathic overactive bladder volunteers and to compare urodynamic findings between the two groups. DESIGN: Eighteen women with multiple sclerosis-associated overactive bladder and 17 women with overactive bladder responded the overactive bladder V8 questionnaire and performed urodynamic study with electromyography of pelvic floor muscle to confirm the presence of a 15-sec pelvic floor muscle contraction during a detrusor overactivity, when present. Variables were the following: overactive bladder-V8 questionnaire, maximum cystometric capacity, volume at first detrusor overactivity, maximum detrusor overactivity amplitude, and percentage of detrusor overactivity pressure reduction. RESULTS: All participants had a reduction in detrusor overactivity pressure when pelvic floor muscle contraction was requested. Multiple sclerosis-associated overactive bladder group showed significant higher detrusor overactivity amplitude than overactive bladder group (P = 0.02). Overactive bladder group had their detrusor overactivity pressure reduced in a greater extent when compared with multiple sclerosis-associated overactive bladder group (P = 0.01). CONCLUSIONS: The results suggest that pelvic floor muscle contraction is able to reduce detrusor overactivity pressure in multiple sclerosis-associated overactive bladder and overactive bladder population.

Fatores associados à dependência funcional em idosos restritos ao lar / Factors associated with functional dependency in older adults restricted to the home

Objetivo: identificar os fatores sociodemográficos e econômicos associados a diferentes níveis de dependência funcional em idosos restritos ao lar assistidos por uma Unidade de Saúde da Família de Vitória (ES). Métodos: Pesquisa transversal de 101 idosos com dependência funcional e restritos ao lar. Perfil sociodemográfico e econômico foi obtido através de questionário; dependência funcional foi aferida através da Escala Medida de Independência Funcional. Foram realizados os testes Chi-quadrado de Pearson ou Exato de Fisher e Razão de Prevalência. Resultados: Verificou-se que 43,5% dos idosos apresentaram dependência leve e 56,4% dependência moderada/grave. A maioria dos idosos era do sexo feminino, com idade ≥ 80 anos, brancos, viúvos, baixa escolaridade, aposentados, baixa renda, contribuíam para renda familiar, com filhos, com cuidador, relataram ter passado a maior parte da vida na cidade, residindo em bairro nobre e em residências multigeracionais. Verificou-se como variáveis associadas aos diferentes níveis de dependência funcional idade ≥ 80 anos (p = 0,018), ocupação (p = 0,033) e renda (p = 0,036). Conclusão: Se comportaram com fatores associados aos diferentes níveis de dependência funcional: idade ≥ 80 anos, ocupação e renda. (AU)

Objective: to identify sociodemographic and economic factors associated with different levels of functional dependency in older adults restricted to the home, assisted by a Family Health Unit of Vitória, ES. Methods: A cross-sectional survey of 101 older people with functional dependency and restricted to the home. Sociodemographic and economic profiles were obtained through questionnaire; Functional dependency was measured through the Functional Independence Measure scale. Pearson's Chi-square or Fisher's Exact and Prevalence Ratio tests were performed. Results: It was found that 43.5% of the older adults had mild dependency and 56.4% had moderate/severe dependency. The majority of the older adults were female, aged 80 and over, white, widowers, low schooling, retirees, low income, contributed to family income, with children, with caregiver, reported having spent most of their lives in the city residing in middle-class neighborhoods and multigenerational residences. The variables associated with the different levels of functional dependency were the fourth age (p = 0.018), occupation (p = 0.033) and income (p = 0.036). Conclusion: Behaved with factors associated with different levels of functional dependency age ≥ 80 years, occupation and income. (AU)

Arm motor recovery using a virtual reality intervention in chronic stroke: randomized control trial.

INTRODUCTION: Despite interest in virtual environments (VEs) for poststroke arm motor rehabilitation, advantages over physical environment (PE) training have not been established. OBJECTIVE: The authors compared kinematic and clinical outcomes of dose-matched upper-limb training between a 3D VE and a PE in chronic stroke. METHODS: Participants (n = 32) were randomized to a 3D VE or PE for training. They pointed to 6 workspace targets (72 trials, 12 trials/target, randomized) for 12 sessions over 4 weeks with similar feedback on precision, movement speed, and trunk displacement. Primary (kinematics, clinical arm motor impairment) and secondary (activity level, arm use) outcomes were compared by time (PRE, POST, and follow-up, RET), training environment, and impairment severity (mild, moderate-to-severe) using mixed-model analyses of variance (ANOVAs). RESULTS: Endpoint speed, overall performance on a reach-to-grasp task, and activity levels increased in both groups. Only participants in the VE group improved shoulder horizontal adduction at POST (9.5°) and flexion at both POST (6.3°) and RET (13°). Impairment level affected outcomes. After VE training, the mild group increased elbow extension (RET, 25.5°). The moderate-to-severe group in VE increased arm use at POST (0.5 points) and reaching ability at RET (2.2 points). The moderate-to-severe group training in PE increased reaching ability earlier (POST, 1.7 points) and both elbow extension (10.7°) and arm use (0.4 points) at RET, but these changes were accompanied by increased compensatory trunk displacement (RET, 30.2 mm). CONCLUSION: VE training led to more changes in the mild group and a motor recovery pattern in the moderate-to-severe group indicative of less compensation, possibly because of a better use of feedback.

Prevalência e fatores associados à dependência funcional em idosos restritos ao lar / Prevalence and factors associated with functional dependency in homebound elderly people in Brazil

INTRODUCTION: Population ageing is a worldwide reality that requires attention, and a concern for healthy and functional ageing is increasingly the focus of government policies and programmes. OBJECTIVE: To identify the prevalence of homebound elderly people, and the influence of sociodemographic and economic characteristics on their functional dependency. METHODS: Cross-sectional study with 178 homebound elderly people assisted by a family healthcare unit in Vitória, ES, Brazil. Functional independence was measured by the Functional Independence Measure (FIM) and the sociodemographic and economic variables were collected by a questionnaire developed by the authors. Binary logistic regression was used to determine the influence of the sociodemographic and economic characteristics on the risk of being functionally dependent. RESULTS: Forty-eight percent of the participants were functional dependents, 80% were female, 72% belonged to the fourth age, 74% were white, 63% were widowed, 78% had retired, 90% had children, 83% had a caregiver, 52% had low education and 40% had low income. Logistic regression indicated that having a caregiver increased by 40 times the chance of being functionally dependent (OR = 40.2; 95%CI 4.8-355.4) and having between one to eight years of education decreased the chance of functional dependency (OR = 0.2; 95%CI 0.04-0.9). CONCLUSIONS: The prevalence of functional dependency was very high in this sample, and since the presence of a caregiver was the strongest and significant predictor of functional dependency, we suggest that guidance and support should be offered to caregivers, followed by a family healthcare strategy, to make consistent efforts with the objective of improving functional recovery and independence of homebound elderly.

INTRODUÇÃO: O envelhecimento populacional é uma realidade de proporções mundiais que requer atenção, e a preocupação com o envelhecimento saudável e funcional é cada vez mais o foco de políticas e programas do governo. OBJETIVO: Verificar a prevalência e influência dos fatores sócio demográficos e econômicos na dependência funcional em idosos restritos ao lar. MÉTODO: Estudo transversal com 178 idosos restritos ao lar assistidos por uma Unidade de Saúde da Família de Vitória-ES. Aferiu-se a dependência funcional através da Medida de Independência Funcional e coletou-se variáveis para caracterização o perfil dos idosos. Utilizou-se a Regressão Logística Binária para determinar o nível de predição da dependência funcional. RESULTADOS: Quarenta e oito por cento dos idosos apresentavam dependência funcional, 80% eram do sexo feminino, 72% na 4º idade, 74% brancos, 63% viúvos, 78% aposentados, 90% com filhos, 83% com cuidador, 52% com baixa escolaridade e 40% com baixa renda. A presença de cuidador se comportou como preditor da dependência funcional (OR=40.2; IC95% 4,8-355,4) e a escolaridade entre 1 e 8 anos se mostrou como fator de proteção (OR=0,2; IC95% 0,04-0,9). CONCLUSÃO: A prevalência dependência funcional mostrou-se elevada, e a presença de cuidador figurou como um forte e significante preditor, propõe-se o estabelecimento de 'suporte' para o cuidador mediado pelas equipes da Estratégia Saúde da Família para manutenção/recuperação da funcionalidade dos longevos.

Doenças respiratórias em crianças e adolescentes: um perfil dos atendimentos na atenção primária em Vitória/ES / Respiratory diseases in children and adolescents: profiling primary care visits in Vitória/ES / Enfermedades respiratorias en niños y adolescentes: un perfil de asistencia en la atención primaria en Vitória/ES

Objetivo: Identificar las principales causas de enfermedades respiratorias en la atención primaria, en Vitória, ES, para residentes de edades entre 0 y 19 años, relacionar su gravedad con la edad y el estatus socioeconómico y verificar la variación temporal en la frecuencia de estas visitas. Métodos: Estudio descriptivo transversal de las visitas realizadas en el 2014 en las 30 unidades básicas de salud de la ciudad de Vitória, con datos del sistema de registros electrónicos Rede Bem Estar. Se realizó un análisis descriptivo de las variables sociodemográficas, grupos diagnósticos y mes de atención y regresión logística entre la topografía del tracto respiratorio y las variables sociodemográficas. Resultados: De los 113.252 casos de 0 a 19 años de edad, las enfermedades respiratorias fueron las más frecuentes (28.810, 25,43% del total, 40,18% de las visitas por enfermedad), especialmente las "Infecciones agudas de las vías respiratorias superiores" (61,35%), las "Enfermedades crónicas de las vías respiratorias inferiores" (14,60%) y "Otras enfermedades de las vías aéreas superiores" (8,69%). La proporción de asistencias disminuyó con la edad y fue mayor entre los residentes de los vecindarios de ingresos promedios más bajos. Las vías aéreas superiores fueron más afectadas en todos los grupos de edad, especialmente en los más avanzados, y entre los residentes de los barrios de ingreso familiar promedio más alto. Sin embargo, sólo el 6% de la varianza de la distribución según la topografía del aparato respiratorio se explicó por grupo de edad y estado socioeconómico. Se observó un aumento de las asistencias en los meses de marzo a noviembre. Conclusiones: Las enfermedades respiratorias tienen un gran impacto en la población pediátrica de Vitória. Se recomiendan medidas de prevención primaria y secundaria que tengan en cuenta la multi-causalidad implicada en la determinación de estas enfermedades.

Objective: To identify the main reasons for visiting a primary health care facility among 0-19 year old residents with respiratory diseases, as well as their frequency, and to associate the severity of those diseases with age and socioeconomic status. Methods: A descriptive cross-sectional study was conducted on all visits to any of the 30 basic health units of the city of Vitória, ES in 2014, using the electronic database Rede Bem Estar. A descriptive analysis was carried out on sociodemographic variables, diagnostic groups and the month of these visits, in addition to logistic regression between the topography of the impairment of the respiratory system and sociodemographic variables. Results: Respiratory diseases were the most frequent reason for visiting the primary health care facility among all 113,252 0-19 years old participants included in the study (28,810, corresponding to 25.43% of the total and 40.18% of visits due to illness), particularly "acute upper respiratory infections" (61.35%), "chronic lower respiratory diseases" (14.60%), and "other diseases of the upper airways" (8.69%). The months of March to November showed higher frequency of visits, and the visit rates decreased with age, proving to be higher among residents of neighborhoods with lower average income. The upper airways were more affected in all age groups, especially in the older ones, and in residents of higher average income neighborhoods. However, only 6% of the variance of the distribution based on the topography of the impairment of the respiratory system was explained by age group and socioeconomic status. Conclusions: Respiratory diseases have a major impact on the pediatric population in Vitória. Primary and secondary prevention measures are recommended, taking into account the multi-causality involved in determining these diseases.

Resumo Objetivo: Identificar as principais causas de atendimento por doenças respiratórias na atenção primária, em Vitória, ES, nos residentes de 0­19 anos, relacionando a gravidade das mesmas com idade e nível socioeconômico, e verificar a variação temporal de frequência desses atendimentos. Métodos: Estudo transversal descritivo dos atendimentos realizados em 2014 nas 30 unidades básicas de saúde do município de Vitória, com dados do sistema de registros eletrônicos Rede Bem Estar. Realizou-se análise descritiva das variáveis sociodemográficas, grupos de diagnóstico e mês de atendimento e regressão logística entre topografia de acometimento do aparelho respiratório e variáveis sociodemográficas. Resultados: Dos 113.252 atendimentos de 0­19 anos, doenças respiratórias constituíram as causas mais frequentes (28.810, 25,43% do total, 40,18% dos atendimentos por doença), destacando-se "Infecções agudas das vias aéreas superiores" (61,35%), "Doenças crônicas das vias aéreas inferiores" (14,60%) e "Outras doenças das vias aéreas superiores" (8,69%). A proporção de atendimentos caiu com a idade e foi maior entre residentes em bairro de menor renda domiciliar média. As vias aéreas superiores foram mais acometidas em todas as faixas etárias, principalmente nas mais avançadas, e nos residentes em bairros de maior renda domiciliar média. Porém, apenas 6% da variância da distribuição segundo topografia de acometimento do aparelho respiratório foi explicada por faixa etária e nível socioeconômico. Observou-se crescimento dos atendimentos nos meses de março a novembro. Conclusões: Doenças respiratórias são agravos de grande impacto na população pediátrica em Vitória. Recomendam-se medidas de prevenção primária e secundária que levem em consideração a multicausalidade envolvida na determinação dessas doenças.