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In clinical and translational research, data science is often and fortuitously integrated with data collection. This contrasts to the typical position of data scientists in other settings, where they are isolated from data collectors. Because of this, effective use of data science techniques to resolve translational questions requires innovation in the organization and management of these data.
We propose an operational framework that respects this important difference in how research teams are organized. To maximize the accuracy and speed of the clinical and translational data science enterprise under this framework, we define a set of eight best practices for data management.
In our own work at the University of Rochester, we have strived to utilize these practices in a customized version of the open source LabKey platform for integrated data management and collaboration. We have applied this platform to cohorts that longitudinally track multidomain data from over 3000 subjects.
We argue that this has made analytical datasets more readily available and lowered the bar to interdisciplinary collaboration, enabling a team-based data science that is unique to the clinical and translational setting.
OBJECTIVES/GOALS: The Mayo Clinic Clinical and Translational Science (CTS) Predoctoral program aims to develop independent researchers capable of leading multi-disciplinary teams to accelerate the translation of discovery to application. Here, we detail the outcomes of our graduates over the past ten years (2010-2019). METHODS/STUDY POPULATION:): A survey was fielded with all CTS graduates whose degrees were conferred since the program’s inception to 2019. Items addressed their current position, whether they were still involved in research, what type of research they were involved in, and whether they stayed involved with education. They also submitted a recent CV, from which data were collected about publications and grants. A subset were then contacted for a semi-structured interview. Items included questions addressing motivation for pursuing a PhD in CTS, whether the program prepared them for their current work, gaps they felt they had in training, and whether they felt they were making a difference in the lives of patients. RESULTS/ANTICIPATED RESULTS: Of the 41 alumni, 34 responded (83% response rate). Of these, 19 (56%) are at Mayo Clinic, 9 (26%) work for other academic institutions, and 6 (21%) do not work for an academic institution. Most have remained in research (33/34, 97%). The majority (22/33, 67%) are involved in clinical research, 30% (10/33) in basic science, and 24% (8/33) in healthcare delivery research. Most (23/34, 68%) are engaged in educational activities. When asked about changes they have led, 67% (18/27) led quality improvement projects and 44% (12/27) designed a new research method. Several hold leadership positions either in their organization (12/16, 75%) or in a professional organization (10/16, 63%). DISCUSSION/SIGNIFICANCE OF IMPACT: The CTS Predoctoral program successfully prepares scholars for careers involving clinical and translational research; furthermore, alumni remain in research-oriented careers after graduation. We will continue to gather longitudinal data alumni move forward in their careers.
Although there is some evidence that duration of untreated psychosis (DUP) is geographically stable, few have examined whether the phenomenon is temporally stable. We examined DUP in two cohorts within two discrete time periods (1995–1999 and 2003–2005) spanning a decade in the same geographically defined community psychiatric service with no early intervention programme. Patients were diagnosed by Structured Clinical Interview for DSM (SCID) and we determined the DUP using the Beiser Scale. The DUP of the 240 participants did not differ significantly between study periods.
Item 9 of the Patient Health Questionnaire-9 (PHQ-9) queries about thoughts of death and self-harm, but not suicidality. Although it is sometimes used to assess suicide risk, most positive responses are not associated with suicidality. The PHQ-8, which omits Item 9, is thus increasingly used in research. We assessed equivalency of total score correlations and the diagnostic accuracy to detect major depression of the PHQ-8 and PHQ-9.
We conducted an individual patient data meta-analysis. We fit bivariate random-effects models to assess diagnostic accuracy.
16 742 participants (2097 major depression cases) from 54 studies were included. The correlation between PHQ-8 and PHQ-9 scores was 0.996 (95% confidence interval 0.996 to 0.996). The standard cutoff score of 10 for the PHQ-9 maximized sensitivity + specificity for the PHQ-8 among studies that used a semi-structured diagnostic interview reference standard (N = 27). At cutoff 10, the PHQ-8 was less sensitive by 0.02 (−0.06 to 0.00) and more specific by 0.01 (0.00 to 0.01) among those studies (N = 27), with similar results for studies that used other types of interviews (N = 27). For all 54 primary studies combined, across all cutoffs, the PHQ-8 was less sensitive than the PHQ-9 by 0.00 to 0.05 (0.03 at cutoff 10), and specificity was within 0.01 for all cutoffs (0.00 to 0.01).
PHQ-8 and PHQ-9 total scores were similar. Sensitivity may be minimally reduced with the PHQ-8, but specificity is similar.
This paper reflects on the latent organisational process that leads tothe scarcity of women in senior positions. Utilising characteristics of legitimisation, institutionalisation and self-determination theories the paper observes how women manage upward mobility. Subsequently, it was important to investigate the mid-level cohorts, as there lies the critical question triggering the anomaly. Focusing on the public sector with an interest in gendered organisations, the study examines law enforcement. Conversely, the aim of this paper is to focus on why there is a continued dearth in the number of policewomen at top level positions in USA and Australia. A qualitative study with a phenomenological approach is applied. Semi-structured interviews are conducted with 40 policewomen in mid-management positions in American and Australian law enforcement. It further aims to explore the linkages of the ongoing paucity of gendered leadership in organisations, questioning how these will influence women's ability to advance to higher-level positions.
Neurocognition is one of the strongest predictors of clinical and functional outcomes across the spectrum of psychopathology, yet there remains a dearth of unified neurocognitive nosology and available neurocognition-targeted interventions. Neurocognitive deficits manifest in a transdiagnostic manner, with no psychiatric disorder uniquely affiliated with one specific deficit. In fact, recent research has identified that essentially all investigated disorders are comprised of 3–4 neurocognitive profiles. This within-disorder neurocognitive heterogeneity has hampered the development of novel, neurocognition-targeted interventions, as only a portion of patients with any given disorder possess neurocognitive deficits that would warrant neurocognitive intervention. The development of criteria and terminology to characterize these neurocognitive deficit syndromes would provide clinicians with the opportunity to more systematically identify and treat their patients and provide researchers the opportunity to develop neurocognition-targeted interventions for patients. This perspective will summarize recent work and discuss possible approaches for neurocognition-focused diagnosis and treatment in psychiatry.
Improving Access to Psychological Therapies (IAPT) services treat most patients in England who present to primary care with major depression. Psychodynamic psychotherapy is one of the psychotherapies offered. Dynamic Interpersonal Therapy (DIT) is a psychodynamic and mentalization-based treatment for depression. 16 sessions are delivered over approximately 5 months. Neither DIT's effectiveness relative to low-intensity treatment (LIT), nor the feasibility of randomizing patients to psychodynamic or cognitive-behavioural treatments (CBT) in an IAPT setting has been demonstrated.
147 patients were randomized in a 3:2:1 ratio to DIT (n = 73), LIT (control intervention; n = 54) or CBT (n = 20) in four IAPT treatment services in a combined superiority and feasibility design. Patients meeting criteria for major depressive disorder were assessed at baseline, mid-treatment (3 months) and post-treatment (6 months) using the Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory-II (BDI-II) and other self-rated questionnaire measures. Patients receiving DIT were also followed up 6 months post-completion.
The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70). Significantly more DIT patients (51%) showed clinically significant change on the HRSD-17 compared with LIT (9%). The DIT and CBT arms showed equivalence on most outcomes. Results were similar with the BDI-II. DIT showed benefit across a range of secondary outcomes.
DIT delivered in a primary care setting is superior to LIT and can be appropriately compared with CBT in future RCTs.
OBJECTIVES/SPECIFIC AIMS: The objective of this research was to assess the clinical impact of simulation-based team leadership training on team leadership effectiveness and patient care during actual trauma resuscitations. This translational work addresses an important gap in simulation research and medical education research. METHODS/STUDY POPULATION: Eligible trauma team leaders were randomized to the intervention (4-hour simulation-based leadership training) or control (standard training) condition. Subject-led actual trauma patient resuscitations were video recorded and coded for leadership behaviors (primary outcome) and patient care (secondary outcome) using novel leadership and trauma patient care metrics. Patient outcomes for trauma resuscitations were obtained through the Harborview Medical Center Trauma Registry and analyzed descriptively. A one-way ANCOVA analysis was conducted to test the effectiveness of our training intervention versus a control group for each outcome (leadership effectiveness and patient care) while accounting for pre-training performance, injury severity score, postgraduate training year, and days since training occurred. Association between leadership effectiveness and patient care was evaluated using random coefficient modeling. RESULTS/ANTICIPATED RESULTS: Sixty team leaders, 30 in each condition, completed the study. There was a significant difference in post-training leadership effectiveness [F(1,54)=30.19, p<.001, η2=.36] between the experimental and control conditions. There was no direct impact of training on patient care [F(1,54)=1.0, p=0.33, η2=.02]; however, leadership effectiveness mediated an indirect effect of training on patient care. Across all trauma resuscitations team leader effectiveness correlated with patient care (p<0.05) as predicted by team leadership conceptual models. DISCUSSION/SIGNIFICANCE OF IMPACT: This work represents a critical step in advancing translational simulation-based research (TSR). While there are several examples of high quality translational research programs, they primarily focus on procedural tasks and do not evaluate highly complex skills such as leadership. Complex skills present significant measurement challenges because individuals and processes are interrelated, with multiple components and emergent nature of tasks and related behaviors. We provide evidence that simulation-based training of a complex skill (team leadership behavior) transfers to a complex clinical setting (emergency department) with highly variable clinical tasks (trauma resuscitations). Our novel team leadership training significantly improved overall leadership performance and partially mediated the positive effect between leadership and patient care. This represents the first rigorous, randomized, controlled trial of a leadership or teamwork-focused training that systematically evaluates the impact on process (leadership) and performance (patient care).
The Paleolithic diet excludes two major sources of fibre, grains and legumes. However, it is not known whether this results in changes to resistant starch (RS) consumption. Serum trimethylamine-N-oxide (TMAO) is produced mainly from colonic fermentation and hepatic conversion of animal protein and is implicated in CVD, but changes in RS intake may alter concentrations. We aimed to determine whether intake of RS and serum concentrations of TMAO varied in response to either the Paleolithic or the Australian Guide to Healthy Eating (AGHE) diets and whether this was related to changes in food group consumption. A total of thirty-nine women (mean age 47 (sd 13) years, BMI 27 (sd 4) kg/m2) were randomised to AGHE (n 17) or Paleolithic diets (n 22) for 4 weeks. Serum TMAO concentrations were measured using liquid chromatography–MS; food groups, fibre and RS intake were estimated from weighed food records. The change in TMAO concentrations between groups (Paleolithic 3·39 μmv. AGHE 1·19 μm, P = 0·654) did not reach significance despite greater red meat and egg consumption in the Paleolithic group (0·65 serves/d; 95 % CI 0·2, 1·1; P <0·01, and 0·22 serves/d; 95 % CI 0·1, 0·4, P <0·05, respectively). RS intake was significantly lower on the Paleolithic diet (P <0·01) and was not associated with TMAO concentrations. However, the limited data for RS and the small sample size may have influenced these findings. While there were no significant changes in TMAO concentrations, increased meat consumption and reduced RS intake warrant further research to examine the markers of gastrointestinal health of Paleolithic diet followers and to update Australian food databases to include additional fibre components.
Depression and cognitive impairment are highly prevalent in type 2 diabetes (T2D), yet little is known about how their relationship varies by sex. We examined this question in a large T2D sample (N = 897) of non-demented elderly (≥ 65) participating in the Israel Diabetes and Cognitive Decline (IDCD) Study. Cognition was evaluated by a comprehensive neuropsychological battery and depressive symptoms were assessed by the Geriatric Depression Scale (GDS). The results showed that in all but the executive function domain, the association of depressive symptoms with poorer cognitive function was stronger in women than men, with a significant interaction for language/semantic categorization and missed significance for episodic memory. When defining clinical depression as GDS of ≥6, women with depression had significantly poorer language/semantic categorization, episodic memory, and overall cognitive function. Inclusion of antidepressants in the model did not alter substantively the associations. Our results suggest that depressed T2D women may have poorer cognitive performance, highlighting the significance of sex-specific personalized management of depression in elderly diabetics.
Different diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.
To evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics.
Data collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit.
A total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15–3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98–10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7–15) (OR = 0.96; 95% CI = 0.56–1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26–0.97).
The MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.
Declaration of interest
Drs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.
There is no consensus as to whether magnetic resonance imaging (MRI) should be used as part of the initial clinical evaluation of patients with first-episode psychosis (FEP).
(a) To assess the logistical feasibility of routine MRI; (b) to define the clinical significance of radiological abnormalities in patients with FEP.
Radiological reports from MRI scans of two FEP samples were reviewed; one comprised 108 patients and 98 healthy controls recruited to a research study and the other comprised 241 patients scanned at initial clinical presentation plus 66 healthy controls.
In the great majority of patients, MRI was logistically feasible. Radiological abnormalities were reported in 6% of the research sample and in 15% of the clinical sample (odds ratio (OR) = 3.1, 95% CI 1.26–7.57, χ2(1) = 6.63, P = 0.01). None of the findings necessitated a change in clinical management.
Rates of neuroradiological abnormalities in FEP are likely to be underestimated in research samples that often exclude patients with organic abnormalities. However, the majority of findings do not require intervention.
OBJECTIVES/SPECIFIC AIMS: The Institute for Transnational Sciences (ITS) has developed novel methods to ethically engage stakeholders across the transnational research spectrum, up to and including public health practice and policy. METHODS/STUDY POPULATION: In 2014, the ITS co-founded The Research, Education, And Community Health (REACH), the mission of which was to facilitate communication, collaborative research, and service activities between faculty and scientists and area community leaders. The intent was to identify and meet the needs of our communities without gaps and/or redundancies, thus better leveraging time, funding, and efforts. RESULTS/ANTICIPATED RESULTS: REACH now boasts 23 Centers, Departments, and Institutes, as well as 39 community organizations, including public and mental health agencies, clinicians, policy makers, family service centers, cultural and faith-based organizations, business, and local schools/colleges. We offer 3 methods for consideration as best practices: (1) a comprehensive community health needs assessment, (2) an “Offer and Ask” community/campus partnership mechanism, and (3) Community Science Workshops, based on the European Union’s Science Shops. DISCUSSION/SIGNIFICANCE OF IMPACT: Results of REACH’s work have been used to provide guidance for enhanced, data-driven programs and allocation of resources for local and statewide initiatives. The organization has evolved into an independent coalition seeking 501(c)3 status and is planning to expand its scope to 5 counties. REACH thus serves as model for successful replication across applicable CTSA hubs.
Electronic health records (EHRs) provide great promise for identifying cohorts and enhancing research recruitment. Such approaches are sorely needed, but there are few descriptions in the literature of prevailing practices to guide their use. A multidisciplinary workgroup was formed to examine current practices in the use of EHRs in recruitment and to propose future directions. The group surveyed consortium members regarding current practices. Over 98% of the Clinical and Translational Science Award Consortium responded to the survey. Brokered and self-service data warehouse access are in early or full operation at 94% and 92% of institutions, respectively, whereas, EHR alerts to providers and to research teams are at 45% and 48%, respectively, and use of patient portals for research is at 20%. However, these percentages increase significantly to 88% and above if planning and exploratory work were considered cumulatively. For most approaches, implementation reflected perceived demand. Regulatory and workflow processes were similarly varied, and many respondents described substantive restrictions arising from logistical constraints and limitations on collaboration and data sharing. Survey results reflect wide variation in implementation and approach, and point to strong need for comparative research and development of best practices to protect patients and facilitate interinstitutional collaboration and multisite research.
Today, we want to reconsider heritage by investigating the ways it relates to past and present definitions of human life. We will begin by analyzing how war changed the definition of life and shifted the emphasis from maternal authority to infant welfare. With a blend of history, theory, and literature, we will demonstrate how a changing definition not only affected the ways in which both men and women were governed, but determines how our society will be managed. Our paper demonstrates the ways Virginia Woolf's Three Guineas represents a heritage that pays attention to the history of women, specifically to aspects of culture that have previously been ignored.
Woolf constructs heritage in Three Guineas around the history of women's loss of authority over their bodies and around the rising emphasis on fetal life. Viewed through the lens of biopolitics, Virginia Woolf's Three Guineas presents an inextricable link between reproduction and war aggression. Stephen Barber uses ideas of feminism with Michel Foucault's biopolitics to help us understand the tie between patriarchal constructs and warfare. Culture takes control over the individual body and manipulates it to be both forceful and docile. The regulation of the body, Foucault's second notion, focuses more on how we work to improve the population and to control life as a whole, such as socially encouraging women to stay in the home and continue to populate the country. With such insights, we can see how Three Guineas articulates how culture disciplines and regulates bodies to serve as weapons.
Biopolitics has been used extensively to study a variety of things from concepts of social immunity to sexual behavior, as well as pointing out the connections between literature and biopolitics (see, for example, Olin-Hitt). However, almost no attention has been devoted to biopolitics in regards to disciplining the maternal and fetal body. Before we turn to Woolf, we will first briefly outline how definitions of maternal and fetal life changed in those pivotal years from the end of the nineteenth century to the beginning of the twentieth century. The history reveals an entire redefinition of infant and maternal life that leads to both the aggressive domestic and war-driven international society that Woolf so thoroughly rejects in Three Guineas.
The volume of maritime vessel data, such as available from the Automatic Identification System (AIS), places considerable burden on systems designed and developed to manage data pertaining to maritime traffic. A properly designed and implemented data management infrastructure can provide benefits to the maritime domain awareness research community by supporting data volumes, diverse user needs, and product management. Such an infrastructure has been constructed on a modest budget by utilising open-source technologies. This paper describes the Maritime Situational Awareness Research Infrastructure (MSARI), and the design of the underlying database to meet data volume and user analysis needs. The resulting infrastructure currently handles input rates of approximately two billion vessel reports per month. This work is of potential benefit to those in the navigational community interested in the long-term storage and usage of global vessel data such as that available from AIS.
To compare the energy, nutrient and food group compositions of three sources of school-day lunches among students in five secondary schools in the Republic of Ireland (ROI).
Cross-sectional study conducted between October 2012 and March 2013. Students completed self-report food diaries over two school days. The energy, nutrient, nutrient density and food group composition of school-day lunches from home, school and ‘out’ in local food outlets were compared using ANCOVA and Tukey’s Honest Significant Difference post hoc analysis.
Five secondary schools in the ROI.
Male and female students aged 15–17 years (n 305).
Six hundred and fifteen lunches (376 home lunches, 115 school lunches and 124 lunches sourced ‘out’ in the local environment) were analysed. School and ‘out’ purchased lunches were significantly higher than packed lunches from home in energy (2047 kJ (489 kcal), 2664 kJ (627 kcal), 1671 kJ (399 kcal), respectively), total fat (23·5 g, 30·1 g, 16·6 g, respectively) and free (added) sugars (12·6 g, 19·3 g, 7·4 g, respectively). More home lunches contained more fruit, wholemeal breads, cheese and red meat than lunches from school or ‘out’. Meat products, chips and high-calorie beverages were sourced more frequently at school or ‘out’ than home. Fibre and micronutrient contents of lunches from all sources were low.
Home-sourced lunches had the healthiest nutritional profile in terms of energy and macronutrients. Foods high in energy, fat and free sugars associated with school and local food outlets are of concern given the public health focus to reduce their consumption. While school food should be improved, all sources of lunches need to be considered when addressing the dietary behaviours of secondary-school students.