Generalisable Overview of Study Risk for Lead Investigators Needing Guidance (GOSLING): A data governance risk tool.

INTRODUCTION: Digitisation of patient records, coupled with a moral imperative to use routinely collected data for research, necessitate effective data governance that both facilitates evidence-based research and minimises associated risks. The Generalisable Overview of Study Risk for Lead Investigators Needing Guidance (GOSLING) provides the first quantitative risk-measure for assessing the data-related risks of clinical research projects. METHODS: GOSLING employs a self-assessment designed to standardise risk assessment, considering various domains, including data type, security measures, and public co-production. The tool categorises projects into low, medium, and high-risk tiers based on a scoring system developed with the input of patient and public members. It was validated using both real and synthesised project proposals to ensure its effectiveness at triaging the risk of requests for health data. RESULTS: The tool effectively distinguished between fifteen low, medium, and high-risk projects in testing, aligning with subjective expert assessments. An interactive interface and an open-access policy for the tool encourage researchers to self-evaluate and mitigate risks prior to submission for data governance review. Initial testing demonstrated its potential to streamline the review process by identifying projects that may require less scrutiny or those that pose significant risks. DISCUSSION: GOSLING represents the first quantitative approach to measuring study risk, answering calls for standardised risk assessments in using health data for research. Its implementation could contribute to advancing ethical data use, enhancing research transparency, and promoting public trust. Future work will focus on expanding its applicability and exploring its impact on research efficiency and data governance practices.

Using machine learning to model older adult inpatient trajectories from electronic health records data.

Electronic Health Records (EHR) data can provide novel insights into inpatient trajectories. Blood tests and vital signs from de-identified patients' hospital admission episodes (AE) were represented as multivariate time-series (MVTS) to train unsupervised Hidden Markov Models (HMM) and represent each AE day as one of 17 states. All HMM states were clinically interpreted based on their patterns of MVTS variables and relationships with clinical information. Visualization differentiated patients progressing toward stable 'discharge-like' states versus those remaining at risk of inpatient mortality (IM). Chi-square tests confirmed these relationships (two states associated with IM; 12 states with ≥1 diagnosis). Logistic Regression and Random Forest (RF) models trained with MVTS data rather than states had higher prediction performances of IM, but results were comparable (best RF model AUC-ROC: MVTS data = 0.85; HMM states = 0.79). ML models extracted clinically interpretable signals from hospital data. The potential of ML to develop decision-support tools for EHR systems warrants investigation.

Mediators between perfectionism and eating disorder psychopathology: shape and weight overvaluation and conditional goal-setting.

OBJECTIVE: To examine mediators of the relationship between perfectionism and eating disorder (ED) psychopathology in a clinical sample. METHOD: Participants were 201 women with a DSM-IV diagnosed ED consecutively referred to a specialist outpatient treatment clinic. Participants completed measures of perfectionism, ED psychopathology, shape and weight overvaluation, and conditional goal-setting (CGS). RESULTS: Evaluation of a multivariate mediator model using Baron and Kenny's (1986) four-step mediation methodology showed that shape and weight overvaluation and CGS significantly and uniquely mediated the relation between self-oriented perfectionism (SOP) and restraint, eating concern, shape concern, and weight concern. The mediator model furthered the proportion of explained variance in outcomes beyond the direct effects model by 28-49%. DISCUSSION: The findings support the conclusion that the relationship between SOP and ED psychopathology in women with a clinically diagnosed ED is mediated by shape and weight overvaluation and CGS.

Adherence/Retention Alzheimer's Prevention Initiative Colombia Plan.

INTRODUCTION: The Alzheimer's Prevention Initiative Colombia Trial is a collaborative project involving the Neurosciences Group of Antioquia, Genentech/Roche, and the Banner Alzheimer's Institute, studying whether crenezumab can delay or prevent the clinical onset of Alzheimer's disease in cognitively unimpaired individuals who carry the PSEN1 E280A mutation. In an effort to optimize participant compliance and adherence and maintain interest in the trial for its duration, the Neurosciences Group of Antioquia developed an "Adherence/Retention Plan." This plan identifies potential barriers to trial adherence related to characteristics of the participants and study partners, protocol design, sponsors, investigators, environmental factors, and characteristics of this population in general and identifies potential solutions to these barriers. METHODS: Neurosciences Group of Antioquia designed and implemented a number of strategies including a) a prescreening process that emphasized detailed and staged informed consent involving the participant and family and/or friends, b) a schedule of visits and assessments designed to minimize burden while achieving the trial's aims, c) appointment reminders, d) reimbursement for transportation and missed work, e) meals during study visits, f) birthday cards, g) quarterly newsletters, h) annual in-person feedback meetings, i) a supplemental health plan to participants, and j) a social plan to support family members. All the methods used in this plan were approved by local ethics committees. RESULTS: By the end of the fourth year of the trial, participant retention was 94.0%, with most participants reporting that they felt "very satisfied" with their participation in the trial. DISCUSSION: The Adherence/Retention Plan plays a crucial role in maintaining adherence and compliance needed to achieve the ambitious goals of the Alzheimer's Prevention Initiative-Colombia Autosomal Dominant Alzheimer's Disease Trial and may offer guideposts for other prevention trials.

The role of perfectionism, dichotomous thinking, shape and weight overvaluation, and conditional goal setting in eating disorders.

This study examined the role of perfectionism (self-oriented and socially prescribed), shape and weight overvaluation, dichotomous thinking, and conditional goal setting in eating disorder psychopathology. Perfectionism and shape and weight overvaluation have had longstanding implication in the development and maintenance of eating disorders. A leading evidence-based theory of eating disorders (Fairburn, Cooper & Shafran, 2003) outlines perfectionism as a maintaining mechanism of eating disorder psychopathology and as a proximal risk factor for the development of shape and weight overvaluation. These constructs have been linked to other cognitive processes relevant to eating disorders, specifically, dichotomous thinking and conditional goal setting. Women with DSM-IV eating disorders (N=238) were compared to women in the general community (N=248) and, as hypothesised, scores on measures of these constructs were pronounced in the clinical sample. Hierarchical regression analyses predicting eating disorder psychopathology showed that for both groups, dichotomous thinking and conditional goal setting significantly improved model fit beyond perfectionism and shape and weight overvaluation alone. Self-oriented perfectionism, but not socially prescribed perfectionism, was relevant to eating disorder psychopathology. We discuss the implications for current treatment protocols and early intervention.

Reliability and validity of the Conditional Goal Setting in Eating Disorders Scale (CGS-EDS) among adults with eating disorders.

The aim of this study was to develop and validate a self-report measure of Conditional Goal Setting (CGS) for use among individuals with eating disorders, the Conditional Goal Setting in Eating Disorders Scale (CGS-EDS). The CGS-EDS assesses the degree to which an individual believes that the achievement of happiness is contingent upon the attainment of body shape and weight goals. Women with a DSM-IV diagnosed eating disorder consecutively referred to a specialist outpatient clinic (N=238) completed the CGS-EDS and self-report measures of theoretically related constructs. Exploratory factor analysis indicated a one-factor solution, which accounted for 65% of the variance. The CGS-EDS correlated positively with theoretically related measures of overvaluation of shape and weight, concern with shape and weight, dichotomous thinking, and depression. The alpha reliability of the scale was .92. The CGS-EDS is a valid and reliable measure of CGS in eating disorders and is relevant to cognitive and behavioral models of maintenance and intervention.

Depression in older adults: exploring the relationship between goal setting and physical health.

Depression in older adults is associated with a decreased quality of life, increased physical and emotional suffering and an increased risk of death and is often associated with declining physical health. Older people with physical illness have higher rates of depression and studies have also noted the particularly high rate of co-morbidity between depressive disorder and general medical conditions. However, other studies have shown those suffering from poor physical health do not necessarily become depressed and, in particular, the goal setting style of the individual impacts on the relationship between poor physical health and depression. This study argues that those who are conditional goal setters and suffer from poorer physical health will be more prone to depression as their perceived ability to achieve their goals is negatively impacted. One hundred and eighty-seven participants were recruited for this study. The participants completed the Centre for Epidemiological Studies Depression Inventory and the physical health subscale of the SF-12 Health Survey. Participants were asked to rank their three most important goals and to give the main reason for setting each of their top three goals. The results showed that poorer physical health is associated with higher depression scores. Correlations revealed significant negative associations between physical health and depression, physical health and progress towards goal and progress towards goal and depression. A partial correlation between physical health and depression scores controlling for progress demonstrated that the relationship between physical health and depression is mediated through perceived progress. Implications for clinical practice are highlighted.

The psychosocial impact of cancer: exploring relationships between conditional goal setting and depression.

This study explores depression in cancer patients with reference to conditional goal setting (CGS) theory. CGS theory proposes that depressed individuals believe that personal happiness is conditional upon attainment of specific goals (personal CGS). Other individuals may set important goals believing that goal achievement is a necessary prerequisite of social acceptance and approval (social CGS). CGS has been found to contribute to depression in normal populations. 15.2% of the 67 newly diagnosed cancer patients in this study showed clinical levels of depression. A significant relationship was identified between personal CGS, rumination and depression, as predicted in CGS theory. Two months later, 46.7% of patients demonstrated clinical levels of depression. This later experience of depression was significantly related to social CGS. The results suggest CGS involving a misdirected pursuit of happiness is initially associated with depression whereas subsequent experiences of depression are related to a misdirected pursuit of social acceptance. Implications are discussed in terms of understanding the cancer patients' motivations controlling goal setting. It is suggested that successful psychotherapy for depression in cancer patients needs to examine the motivations controlling goal setting in addition to the process of goal pursuit.

Understanding the relationships between wellbeing, goal-setting and depression in children.

OBJECTIVES: This study investigates children's conceptions of happiness and wellbeing in relation to goal choice. It examines the prevalence and impact of Conditional goal setting (CGS) on levels of wellbeing and depression. Conditional goal setting describes commitment toward an important goal resulting from a conception that happiness is an end-point achieved through the attainment of this goal. Conditional goal setting has been identified as a significant factor in the development and maintenance of depression in adults. This study examines these same concepts among children. METHOD: Combined interpretative and quantitative methodology is used. Thirty-six children aged 10-12 years participated in six focus groups discussing their understandings of happiness, important goals and beliefs concerning CGS. Children each attended one of three primary schools in the Perth metropolitan district. They also completed CGS and depression questionnaires. RESULTS: Responses were categorized into a number of common themes. Response content and the number of responses in each theoretical area were identified and discussed. The majority of participants conceptualized happiness as a goal dependent upon something extrinsic to themselves (such as an achievement or event). Statistical analyses suggested a significant relationship between goal setting styles, conceptualizations of happiness and depression. Depressed children were more likely than non-depressed children to be conditional goal setters. CONCLUSIONS: Findings suggest that some children conceptualize happiness as an outcome that is dependent on their important achievements and acquisitions. This conceptualization is related to depression. Alternatively, non-depressed children tended to conceptualize happiness as a process independent of goal achievement or failure.