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BACKGROUND: Digital technologies, such as wearable devices and smartphone applications (apps), can enable the decentralisation of clinical trials by measuring endpoints in people's chosen locations rather than in traditional clinical settings. Digital endpoints can allow high-frequency and sensitive measurements of health outcomes compared to visit-based endpoints which provide an episodic snapshot of a person's health. However, there are underexplored challenges in this emerging space that require interdisciplinary and cross-sector collaboration. A multi-stakeholder Knowledge Exchange event was organised to facilitate conversations across silos within this research ecosystem. METHODS: A survey was sent to an initial list of stakeholders to identify potential discussion topics. Additional stakeholders were identified through iterative discussions on perspectives that needed representation. Co-design meetings with attendees were held to discuss the scope, format and ethos of the event. The event itself featured a cross-disciplinary selection of talks, a panel discussion, small-group discussions facilitated via a rolling seating plan and audience participation via Slido. A transcript was generated from the day, which, together with the output from Slido, provided a record of the day's discussions. Finally, meetings were held following the event to identify the key challenges for digital endpoints which emerged and reflections and recommendations for dissemination. RESULTS: Several challenges for digital endpoints were identified in the following areas: patient adherence and acceptability; algorithms and software for devices; design, analysis and conduct of clinical trials with digital endpoints; the environmental impact of digital endpoints; and the need for ongoing ethical support. Learnings taken for next generation events include the need to include additional stakeholder perspectives, such as those of funders and regulators, and the need for additional resources and facilitation to allow patient and public contributors to engage meaningfully during the event. CONCLUSIONS: The event emphasised the importance of consortium building and highlighted the critical role that collaborative, multi-disciplinary, and cross-sector efforts play in driving innovation in research design and strategic partnership building moving forward. This necessitates enhanced recognition by funders to support multi-stakeholder projects with patient involvement, standardised terminology, and the utilisation of open-source software.
Subject(s)
Clinical Trials as Topic , Endpoint Determination , Stakeholder Participation , Humans , Clinical Trials as Topic/methods , Cooperative Behavior , Interdisciplinary Communication , Mobile Applications , Wearable Electronic Devices , Research Design , SmartphoneABSTRACT
INTRODUCTION: Normative cognitive data can help to distinguish pathological decline from normal aging. This study presents normative data from the Cambridge Neuropsychological Test Automated Battery, using linear regression and nonlinear quantile regression approaches. METHODS: Heinz Nixdorf Recall study participants completed Cambridge Neuropsychological Test Automated Battery tests: paired-associate learning, spatial working memory, and reaction time. Data were available for 1349-1529 healthy adults aged 57-84 years. Linear and nonlinear quantile regression analyses examined age-related changes, adjusting for sex and education. Quantile regression differentiated seven performance bands (percentiles: 97.7, 93.3, 84.1, 50, 15.9, 6.7, and 2.3). RESULTS: Normative data show age-related cognitive decline across all tests, but with quantile regression revealing heterogeneous trajectories of cognitive aging, particularly for the test of episodic memory function (paired-associate learning). DISCUSSION: This study presents normative data from Cambridge Neuropsychological Test Automated Battery in mid-to-late life. Quantile regression can model heterogeneity in age-related cognitive trajectories as seen in the paired-associate learning episodic memory measure.
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BACKGROUND: Depressive and anxiety symptoms often co-occur resulting in a debate about common and distinct features of depression and anxiety. METHODS: An exploratory factor analysis (EFA) and a bifactor modelling approach were used to separate a general distress continuum from more specific sub-domains of depression and anxiety in an adolescent community sample (n = 1159, age 14). The Mood and Feelings Questionnaire and the Revised Children's Manifest Anxiety Scale were used. RESULTS: A three-factor confirmatory factor analysis is reported which identified a) mood and social-cognitive symptoms of depression, b) worrying symptoms, and c) somatic and information-processing symptoms as distinct yet closely related constructs. Subsequent bifactor modelling supported a general distress factor which accounted for the communality of the depression and anxiety items. Specific factors for hopelessness-suicidal thoughts and restlessness-fatigue indicated distinct psychopathological constructs which account for unique information over and above the general distress factor. The general distress factor and the hopelessness-suicidal factor were more severe in females but the restlessness-fatigue factor worse in males. Measurement precision of the general distress factor was higher and spanned a wider range of the population than any of the three first-order factors. CONCLUSIONS: The general distress factor provides the most reliable target for epidemiological analysis but specific factors may help to refine valid phenotype dimensions for aetiological research and assist in prognostic modelling of future psychiatric episodes.
Subject(s)
Affect , Anxiety Disorders/diagnosis , Anxiety/diagnosis , Depression/diagnosis , Depressive Disorder/diagnosis , Adolescent , Anxiety/psychology , Anxiety Disorders/psychology , Depression/psychology , Depressive Disorder/psychology , Factor Analysis, Statistical , Female , Humans , Male , Models, Psychological , Surveys and QuestionnairesABSTRACT
BACKGROUND: Adverse family experiences in early life are associated with subsequent psychopathology. This study adds to the growing body of work exploring the nature and associations between adverse experiences over the childhood years. METHODS: Primary carers of 1143 randomly recruited 14-year olds in Cambridgeshire and Suffolk, UK were interviewed using the Cambridge Early Experiences Interview (CAMEEI) to assess family-focused adversities. Adversities were recorded retrospectively in three time periods (early and later childhood and early adolescence). Latent Class Analysis (LCA) grouped individuals into adversity classes for each time period and longitudinally. Adolescents were interviewed to generate lifetime DSM-IV diagnoses using the K-SADS-PL. The associations between adversity class and diagnoses were explored. RESULTS: LCA generated a 4-class model for each time period and longitudinally. In early childhood 69% were allocated to a low adversity class; a moderate adversity class (19%) showed elevated rates of family loss, mild or moderate family discord, financial difficulties, maternal psychiatric illness and higher risk for paternal atypical parenting; a severe class (6%) experienced higher rates on all indicators and almost exclusively accounted for incidents of child abuse; a fourth class, characterised by atypical parenting from both parents, accounted for the remaining 7%. Class membership was fairly stable (~ 55%) over time with escape from any adversity by 14 years being uncommon. Compared to those in the low class, the odds ratio for reported psychopathology in adolescents in the severe class ranged from 8 for disruptive behaviour disorders through to 4.8 for depressions and 2.0 for anxiety disorders. Only in the low adversity class did significantly more females than males report psychopathology. CONCLUSIONS: Family adversities in the early years occur as multiple rather than single experiences. Although some children escape adversity, for many this negative family environment persists over the first 15 years of life. Different profiles of family risk may be associated with specific mental disorders in young people. Sex differences in psychopathologies may be most pronounced in those exposed to low levels of family adversities.
Subject(s)
Adolescent Behavior/psychology , Family Conflict/psychology , Mental Disorders/psychology , Adolescent , Diagnostic and Statistical Manual of Mental Disorders , Female , Humans , Interview, Psychological , Life Change Events , Male , Mental Disorders/diagnosis , Parents , Risk FactorsABSTRACT
The aim of this study is to assess the effective measurement range of Ryff's Psychological Well-being scales (PWB). It applies normal ogive item response theory (IRT) methodology using factor analysis procedures for ordinal data based on a limited information estimation approach. The data come from a sample of 1,179 women participating in a midlife follow-up of a national birth cohort study in the UK. The PWB scales incorporate six dimensions: autonomy, positive relations with others, environmental mastery, personal growth, purpose in life and self-acceptance. Scale information functions were calculated to derive standard errors of measurement for estimated scores on each dimension. Construct variance was distinguished from method variance by inclusion of method factors from item wording (positive versus negative). Our IRT analysis revealed that the PWB measures well-being most accurately in the middle range of the score distribution, i.e. for women with average well-being. Score precision diminished at higher levels of well-being, and low well-being was measured more reliably than high well-being. A second-order well-being factor loaded by four of the dimensions achieved higher measurement precision and greater score accuracy across a wider range than any individual dimension. Future development of well-being scales should be designed to include items that are able to discriminate at high levels of well-being.
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OBJECTIVE: To describe long term outcomes associated with externalising behaviour in adolescence, defined in this study as conduct problems reported by a teacher, in a population based sample. DESIGN: Longitudinal study from age 13-53. SETTING: The Medical Research Council National Survey of Health and Development (the British 1946 birth cohort). PARTICIPANTS: 3652 survey members assessed by their teachers for symptoms of externalising behaviour at age 13 and 15. MAIN OUTCOME MEASURES: Mental disorder, alcohol abuse, relationship difficulties, highest level of education, social class, unemployment, and financial difficulties at ages 36-53. RESULTS: 348 adolescents were identified with severe externalising behaviour, 1051 with mild externalising behaviour, and 2253 with no externalising behaviour. All negative outcomes measured in adulthood were more common in those with severe or mild externalising behaviour in adolescence, as rated by teachers, compared with those with no externalising behaviour. Adolescents with severe externalising behaviour were more likely to leave school without any qualifications (65.2%; adjusted odds ratio 4.0, 95% confidence interval 2.9 to 5.5), as were those with mild externalising behaviour (52.2%; 2.3, 1.9 to 2.8), compared with those with no externalising behaviour (30.8%). On a composite measure of global adversity throughout adulthood that included mental health, family life and relationships, and educational and economic problems, those with severe externalising behaviour scored significantly higher (40.1% in top quarter), as did those with mild externalising behaviour (28.3%), compared with those with no externalising behaviour (17.0%). CONCLUSIONS: Adolescents who exhibit externalising behaviour experience multiple social and health impairments that adversely affect them, their families, and society throughout adult life.
Subject(s)
Conduct Disorder/epidemiology , Adolescent , Adult , Cohort Studies , Conduct Disorder/psychology , Educational Status , Employment/statistics & numerical data , Family Health , Female , Follow-Up Studies , Humans , Interpersonal Relations , Male , Mental Health/statistics & numerical data , Middle Aged , Prognosis , United Kingdom/epidemiology , Young AdultABSTRACT
BACKGROUND: Individual differences in personality influence the occurrence, reporting and outcome of mental health problems across the life course, but little is known about the effects on adult psychological well-being. The aim of this study was to examine long range associations between Eysenck's personality dimensions and psychological well-being in midlife. METHODS: The study sample comprised 1,134 women from the 1946 British birth cohort. Extraversion and neuroticism were assessed using the Maudsley Personality Inventory in adolescence (age 16 years) and early adulthood (age 26). Psychological well-being was assessed at age 52 with a 42-item version of Ryff's Psychological Well-being Scale. Analyses were undertaken within a structural equation modelling framework that allowed for an ordinal treatment of well-being and personality items, and latent variable modelling of longitudinal data on emotional adjustment. The contribution of mental health problems in linking personality variations to later well-being was assessed using a summary measure of mental health (emotional adjustment) created from multiple time-point assessments. RESULTS: Women who were more socially outgoing (extravert) reported higher well-being on all dimensions. Neuroticism was associated with lower well-being on all dimensions. The effect of early neuroticism on midlife well-being was almost entirely mediated through emotional adjustment defined in terms of continuities in psychological/ psychiatric distress. The effect of extraversion was not mediated by emotional adjustment, nor attenuated after adjustment for neuroticism. CONCLUSIONS: Individual differences in extraversion and neuroticism in early adult life influence levels of well-being reported in midlife.
Subject(s)
Personality Development , Personality Disorders/diagnosis , Personality Disorders/epidemiology , Quality of Life/psychology , Adolescent , Adult , Age Factors , Cohort Studies , Female , Humans , Male , Middle Aged , Personality Inventory , Surveys and Questionnaires , United Kingdom/epidemiologyABSTRACT
The General Health Questionnaire is widely used to measure the health status of individuals. Most studies have focused on traditional score values for one or more dimensions of psychopathology. We introduce a new analysis model that is person-centred and uses a latent structure approach to group individuals by a discrete latent variable. Data were drawn from a midlife (age 53) follow up of a national birth cohort study (n = 3035). For both men and women, three groups (latent classes) were sufficient to summarise individuals' reports of recent changes in social functioning. The groups differed in the number and nature of the reported changes. Furthermore, they were shown to differ in terms of: (1) reported general health, (2) in mean scores on the conventional GHQ factors and (3) in several other variables external to the GHQ (happiness in job, ability to express feelings and self-confidence). Latent Class Analysis of positively worded GHQ items defined groups who differ in perceptions of recent positive changes in social functioning. These groups extend the value of individual health profiles afforded by the GHQ by using distinctions between categories in the first and second responses that are usually combined.
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BACKGROUND: Investigations of the structure of psychological well-being items are useful for advancing knowledge of what dimensions define psychological well-being in practice. Ryff has proposed a multidimensional model of psychological well-being and her questionnaire items are widely used but their latent structure and factorial validity remains contentious. METHODS: We applied latent variable models for factor analysis of ordinal/categorical data to a 42-item version of Ryff's psychological well-being scales administered to women aged 52 in a UK birth cohort study (n = 1,179). Construct (predictive) validity was examined against a measure of mental health recorded one year later. RESULTS: Inter-factor correlations among four of the first-order psychological well-being constructs were sufficiently high (> 0.80) to warrant a parsimonious representation as a second-order general well-being dimension. Method factors for questions reflecting positive and negative item content, orthogonal to the construct factors and assumed independent of each other, improved model fit by removing nuisance variance. Predictive validity correlations between psychological well-being and a multidimensional measure of psychological distress were dominated by the contribution of environmental mastery, in keeping with earlier findings from cross-sectional studies that have correlated well-being and severity of depression. CONCLUSION: Our preferred model included a single second-order factor, loaded by four of the six first-order factors, two method factors, and two more distinct first-order factors. Psychological well-being is negatively associated with dimensions of mental health. Further investigation of precision of measurement across the health continuum is required.