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Background: Previous research on concepts that are important to people living with early-stage Parkinson's indicated that 'functional' slowness, fine motor skills, and subtle gait abnormalities are cardinal concepts that are not comprehensively captured by existing patient-reported outcome (PRO) instruments that are used in clinical practice and research to assess symptoms and daily functioning within this patient population. We sought to develop novel PRO instruments to address this unmet need. Methods: PRO instrument development was led by a multidisciplinary research group, including people living with Parkinson's (termed 'patient experts'), as well as patient engagement and involvement, regulatory science, clinical, and outcome measurement experts. A first set of PRO instruments, termed Early Parkinson's Function Slowness (42 items) and Early Parkinson's Mobility (26 items), were drafted to capture 'functional' slowness, fine motor skills, and subtle gait abnormalities. These PRO instruments were used in cognitive debriefing interviews with people living with early-stage Parkinson's (who were not involved with the multidisciplinary research group) to identify issues with relevance, clarity, ease of completion, conceptual overlap, or missing concepts. Results: Sixty people living with early-stage Parkinson's were interviewed, which led to refining the items to 45 for the Early Parkinson's Functional Slowness and 23 for the Early Parkinson's Mobility PRO instruments. Refinement included rewording items to address clarity issues, merging or splitting items to address overlap issues, and adding new items to address missing concepts. The Early Parkinson's Function Slowness PRO instrument resulted in a multidimensional instrument covering upper limb, complex/whole body, general activity, and cognitive functional slowness. The Early Parkinson's Mobility PRO instrument resulted in comprehensive coverage of everyday mobility tasks, with a focus on gait concepts, plus complex/whole body, balance, and lower limb mobility. Conclusions: The Early Parkinson's Function Slowness and Early Parkinson's Mobility PRO instruments aim to address gaps in existing PRO instruments to measure meaningful symptoms and daily functioning in people living with early-stage Parkinson's. Utilizing a meticulous study design led by a multidisciplinary research group that included patient experts helped to ensure that the PRO instruments were patient-centric, content valid, and meaningful from a clinical and measurement perspective. Plain English Summary: Clinical outcome assessment tools can be used to show how a disease impacts a person's daily life. These outcomes are assessed with tools like surveys or questionnaires. In Parkinson's, most of the tools currently available do not reflect the things that are important to people living with early-stage Parkinson's. Instead, these tools were designed to assess people in later stages of the disease. In this study, the research team created two new tools to assess daily functioning in early-stage Parkinson's. People with early-stage Parkinson's were interviewed to test the new tools. The language and questions in the tools were changed based on feedback from the interviews. The tools were reviewed by a large team, including patient experts and healthcare professionals involved in Parkinson's care. Experts in outcome measures and clinical trials also reviewed the tools. The review step ensured that the tools are easy to understand and appropriate for people living with early-stage Parkinson's. The new tools focus on the symptoms and experiences that are most important to people living with early-stage Parkinson's. We hope that the tools will more clearly show the impact of early-stage Parkinson's and how it progresses. Further testing of these new tools is needed. The aim is to use them in future clinical trials to measure the experience of early-stage Parkinson's more accurately. [ABSTRACT FROM AUTHOR]

Background: Many patient reported outcome measures (PROMs) generate single number index scores that summarise responses to different questions within a questionnaire. Although these are valuable as unambiguous indicators of ill-health and changes in health, further information can be gained from examining the questionnaire responses themselves. This has additional importance since the patients' reports are those responses and not the index scores. This paper reanalyses data from two prospective multicentre clinical studies assessing patients' quality of life before and after total knee arthroplasty (TKA) using the EQ-5D-3L. Patients who completed EQ-5D-3L questionnaires at 3 time periods were included from 4 countries (USA, UK, Australia, New Zealand) operated on by the same surgeons using two different knee replacement systems. Descriptive analyses included levels within EQ-5D dimensions and profiles (combinations of dimensions and levels) at baseline and follow-up, including changes over time and differences between implants. Regression analysis quantified the relationship between the profiles and the EQ VAS. Results: Problems with mobility, usual activities and pain & discomfort, in that order, were most frequent for pre-operative patients. There were large improvements in every dimension after surgery, but the time that this was observed differed: for mobility, self-care and anxiety & depression, most of the improvement occurred during the first 10 months; for usual activities and pain & discomfort, over 11–22 months. Analysing profiles, 85% of patients experienced an unequivocal improvement, 5.9% had no change, 3.5% worsened and 5.5% a mixed change at 11–22 months follow-up. Anxiety & depression had the greatest impact on EQ VAS scores; while mobility and usual activities were also important; usual activities was particularly important post-surgery. Conclusions: The value of analysing patients' responses to PROMs questionnaires without using summary scores was confirmed. The results add further detail to existing knowledge about the health problems that TKA patients experience before surgery, improvements after surgery, residual problems that some have, and the time at which improvements are experienced. This was a small study, but its methods may be easily replicated in other studies that use the EQ-5D-3L. It may also be possible to adapt them for other PROMs. [ABSTRACT FROM AUTHOR]

Background: While lifetime history of traumatic brain injury (TBI) is associated with increased risk of disabilities, little is known about disability and TBI among Appalachian and other rural residents. This study aimed to examine if the relationship between lifetime history of TBI with loss of consciousness (LOC) and disability differs by location of living (Appalachian vs. non-Appalachian; rural vs. urban). Methods: We obtained data on lifetime history of TBI with LOC, location of living, and six sources of disability (auditory, visual, cognitive, mobility, self-care related, and independent living-related impairments) from the 2016–2019 Ohio Behavioral Risk Factor Surveillance System. We modeled the disability outcomes with Appalachian living (or rural living), lifetime history of TBI with LOC, and their interaction as independent variables. Results: Of the 16,941 respondents included, 16.9% had a lifetime history of TBI with LOC, 19.5% were Appalachian residents and 22.9% were rural residents. Among Appalachian residents, 56.1% lived in a rural area. Appalachian (ARR = 1.92; 95%CI = 1.71–2.13) and rural residents (ARR = 1.87; 95%CI = 1.69–2.06) who had a lifetime history of TBI with LOC were at greater risk for having any disability compared to non-Appalachian and urban residents without lifetime history of TBI with LOC, respectively. Conclusions: Appalachian and rural living and lifetime history of TBI with LOC are risk factors for disability. Future research and health policies should address mechanisms for this risk as well as access to healthcare services following a TBI among Appalachian and rural residents. [ABSTRACT FROM AUTHOR]

Objectives: Arterial stiffness is a common issue that may represent an indicator of vascular ageing. We aimed to investigate the association of arterial stiffness with the risk of functional disability and mobility limitation in older adults. Design: Prospective cohort study. Setting and Participants: A total of 1699 older adults from the Rugao Longitudinal Ageing Study were included and analysed. Measurements: Arterial stiffness was assessed by brachial-ankle pulse wave velocity (baPWV). Functional disability and mobility limitation were evaluated by the activities of daily living and the Timed Up and Go test, respectively. The associations of baPWV and risk of functional disability and mobility limitation were analysed using logistic regression models. Restricted cubic spline regressions were applied to estimate the possible nonlinear relationships between them. Results: During the 3.5-year follow-up, 97 (10.00%) and 285 (31.11%) individuals were defined as new-onset functional disability and mobility limitation, respectively. After adjusting for confounding factors, elevated baPWV was significantly associated with a higher risk of incident functional disability (odds ratio [OR] 1.18, 95% confidence interval [CI] 1.06–1.31) and mobility limitation (OR 1.08, 95% CI 1.01–1.16). Additionally, consistent results were obtained from the stratified analyses of the different subgroups. Multivariable restricted cubic spline regression analysis further demonstrated that a near-linear association occurred between baPWV and the risk of incident functional disability and mobility limitation (P-overall < 0.01, P-nonlinear > 0.05). Conclusion: Arterial stiffness, as assessed by baPWV, was associated with the risk of functional disability and mobility limitation in this community-based cohort, and these associations were nearly linear. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has led to abrupt restrictions of lile-space mobility. The impact of shelter-in-place orders on older adults' health and well-being is still unclear. Objective: To investigate the relationship between life-space mobility and quality of life (QoL) in older adults with and without frailty during the COVID-19 pandemic. Design: Multicenter prospective cohort study based on structured telephone interviews. Setting: Four geriatric outpatient clinics in the metropolitan area of Sao Paulo, Brazil. Participants: 557 community-dwelling adults aged 60 years and older. Measurements: The Life-Space Assessment was used to measure community mobility before and during the COVID-19 pandemic, and a previously validated decrease of ≥ 5 points defined restricted life-space mobility. Frailty was assessed through the FRAIL (fatigue, resistance, ambulation, illnesses, and loss of weight) scale. The impact of shelter-in-place orders on QoL was evaluated with the question «How is the COVID-19 pandemic affecting your QoL?», to which participants could respond «not at all», «to some extent», or «to a great extent». We used ordinal logistic regressions to investigate the relationship between restricted life-space mobility and impact on QoL, adjusting our analyses for demographics, frailty, comorbidities, cognition, functionality, loneliness, depression, and anxiety. We explored whether frailty modified the association between life-space mobility and impact on QoL. Results: Participants were on average 80±8 years old, 65% were women, and 33% were frail. The COVID-19 quarantine led to a restriction of community mobility in 79% of participants and affected the QoL for 77% of participants. We found that restricted life-space mobility was associated with impact on QoL in older adults during the pandemic, although frailty modified the magnitude of the association (P-value for interaction=0.03). Frail participants who experienced restricted life-space mobility had twice the odds of reporting an impact on QoL when compared with non-frail individuals, with respective adjusted odds ratios of 4.20 (95% CI=2.36–7.50) and 2.18 (95% CI=1.33–3.58). Conclusion: Older adults experienced substantial decreases in life-space mobility during the COVID-19 pandemic, and this unexpected change impacted their QoL. Providers should be particularly watchful for the consequences of abrupt life-space restrictions on frail individuals. [ABSTRACT FROM AUTHOR]

Having the physical function to undertake activities of daily living (ADLs) is essential in order to maintain independence. The aim of this study is to investigate factors associated with physical function in older adults and determine if these associations differ in men versus women. In total, 726 participants (57% men; 73±7 years old) from a population-based cohort, the Southall and Brent Revisited (SABRE) study, completed questionnaires permitting a physical function score (PFS) to be calculated. Detailed phenotyping was performed including cardiovascular (echocardiography and macrovascular and microvascular functions), skeletal muscle (grip strength and oxidative capacity) and lung (pulmonary) function measurements. In a sub-group, maximal aerobic capacity was estimated from a sub-maximal exercise test. In women versus men, the association between grip strength and PFS was nearly 3 times stronger, and the association between microvascular dysfunction and PFS was over 5 times stronger (standardized β-coefficient (95% CI) 0.34 (0.22, 0.45) versus 0.11 (0.01,0.22) and −0.27 (−0.37, −0.17) versus −0.05 (−0.14, 0.04), respectively). In men, the association between cardiorespiratory fitness and PFS was 3 times greater than that in women (standardized β-coefficient (95% CI) 0.33 (0.22, 0.45) versus 0.10 (−0.04, 0.25). Cardiovascular, skeletal muscle and pulmonary factors all contribute to self-reported physical function, but the relative pattern of contribution differs by sex. Grip strength and microvascular function are most strongly associated with physical function in women while cardiorespiratory fitness is most strongly associated with physical function in men. This is relevant to the design of effective interventions that target maintenance of physical function in old age. [ABSTRACT FROM AUTHOR]