Quantifying data quality for clinical trials using electronic data capture.

BACKGROUND: Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. METHODS AND PRINCIPAL FINDINGS: The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. CONCLUSIONS: Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks.

The impact of structured support groups for pregnant South African women recently diagnosed HIV positive.

The authors of this study evaluated a structured 10-session psychosocial support group intervention for newly HIV-diagnosed pregnant South African women. Participants were expected to display increases in HIV disclosure, self-esteem, active coping and positive social support, and decreases in depression, avoidant coping, and negative social support. Three hundred sixty-one pregnant HIV-infected women were recruited from four antenatal clinics in Tshwane townships from April 2005 to September 2006. Using a quasi-experimental design, assessments were conducted at baseline and two and eight months post-intervention. A series of random effects regression analyses were conducted, with the three assessment points treated as a random effect of time. At both follow-ups, the rate of disclosure in the intervention group was significantly higher than that of the comparison group (p<0.001). Compared to the comparison group at the first follow-up, the intervention group displayed higher levels of active coping (t=2.68, p<0.05) and lower levels of avoidant coping (t=-2.02, p<0.05), and those who attended at least half of the intervention sessions exhibited improved self-esteem (t=2.11, p<0.05). Group interventions tailored for newly HIV positive pregnant women, implemented in resource-limited settings, may accelerate the process of adjusting to one's HIV status, but may not have sustainable benefits over time.

Hannah Arendt's Theory of Political Judgment

Hannah Arendt's theory of political judgment has been an ongoing perplexity among scholars who have written on her. As a result, her theory of judgment is often treated as a suggestive but unfinished aspect of her thought. Drawing on a wider array of sources than is commonly utilized, I argue that her theory of political judgment was in fact the heart of her work. Arendt's project, in other words, centered around reestablishing the possibility of political judgment in a modern world that historically has progressively undermined it. In the dissertation, I systematically develop an account of Arendt's fundamentally political and non-sovereign notion of judgment. We discover that individual judgment is not arbitrary, and that even in the complex circumstances of the modern world there are valid structures of judgment which can be developed and dependably relied upon. The result of this work articulates a theory of practical reason which is highly compelling: it provides orientation for human agency which does not rob it of its free and spontaneous character; shows how we can improve and cultivate our political judgment; and points the way toward the profoundly intersubjective form of political philosophy Arendt ultimately hoped to develop.

THE DEVELOPMENT OF THE AMERICAN SOLO TUBA REPERTOIRE

A very good case can be made that no other instrument has experienced as dramatic an increase in artistic solo repertoire as the tuba in the past sixty years. Prior to 1954, the mainstays of the tuba repertoire were trite caricature pieces such as Solo Pomposo, Rocked in the Cradle of the Deep, Beelzebub, and Bombastoso. A few tubists, seeing the tremendous repertoire by great composers written for their brass brethren, took it upon themselves to raise the standard of original compositions for tuba. These pioneers and champions of the tuba accomplished a great deal in the mid to late twentieth century. They structured a professional organization to solidify their ranks, planned and performed in the first tuba recitals at Carnegie Hall, organized the First International Tuba Symposium-Workshop, indirectly created more prestigious positions for tuba specialists at major universities, and improved the quantity and quality of the solo tuba repertoire. This dissertation focuses on the development of the solo repertoire for tuba that happened in the United States because of the tremendous efforts of William Bell, Harvey Phillips, Roger Bobo, and R. Winston Morris. Because of their tireless work, tuba instrumentalists today enjoy a multitude of great solo works including traditional sonatas, concertos, and chamber music as well as cutting edge repertoire written in many genres and accompanied by a variety of mediums. This dissertation attempts to trace the development of the repertoire presenting the works of American composers in varying genres and musical styles from 1962 to present through three performed recitals.

Structured Illumination Microscopy and a Quantitative Image Analysis for the Detection of Positive Margins in a Pre-Clinical Genetically Engineered Mouse Model of Sarcoma.

Intraoperative assessment of surgical margins is critical to ensuring residual tumor does not remain in a patient. Previously, we developed a fluorescence structured illumination microscope (SIM) system with a single-shot field of view (FOV) of 2.1 × 1.6 mm (3.4 mm2) and sub-cellular resolution (4.4 μm). The goal of this study was to test the utility of this technology for the detection of residual disease in a genetically engineered mouse model of sarcoma. Primary soft tissue sarcomas were generated in the hindlimb and after the tumor was surgically removed, the relevant margin was stained with acridine orange (AO), a vital stain that brightly stains cell nuclei and fibrous tissues. The tissues were imaged with the SIM system with the primary goal of visualizing fluorescent features from tumor nuclei. Given the heterogeneity of the background tissue (presence of adipose tissue and muscle), an algorithm known as maximally stable extremal regions (MSER) was optimized and applied to the images to specifically segment nuclear features. A logistic regression model was used to classify a tissue site as positive or negative by calculating area fraction and shape of the segmented features that were present and the resulting receiver operator curve (ROC) was generated by varying the probability threshold. Based on the ROC curves, the model was able to classify tumor and normal tissue with 77% sensitivity and 81% specificity (Youden's index). For an unbiased measure of the model performance, it was applied to a separate validation dataset that resulted in 73% sensitivity and 80% specificity. When this approach was applied to representative whole margins, for a tumor probability threshold of 50%, only 1.2% of all regions from the negative margin exceeded this threshold, while over 14.8% of all regions from the positive margin exceeded this threshold.

Clinician judgment vs formal scales for predicting intracerebral hemorrhage outcomes.

OBJECTIVE: To compare the performance of formal prognostic instruments vs subjective clinical judgment with regards to predicting functional outcome in patients with spontaneous intracerebral hemorrhage (ICH). METHODS: This prospective observational study enrolled 121 ICH patients hospitalized at 5 US tertiary care centers. Within 24 hours of each patient's admission to the hospital, one physician and one nurse on each patient's clinical team were each asked to predict the patient's modified Rankin Scale (mRS) score at 3 months and to indicate whether he or she would recommend comfort measures. The admission ICH score and FUNC score, 2 prognostic scales selected for their common use in neurologic practice, were calculated for each patient. Spearman rank correlation coefficients (r) with respect to patients' actual 3-month mRS for the physician and nursing predictions were compared against the same correlation coefficients for the ICH score and FUNC score. RESULTS: The absolute value of the correlation coefficient for physician predictions with respect to actual outcome (0.75) was higher than that of either the ICH score (0.62, p = 0.057) or the FUNC score (0.56, p = 0.01). The nursing predictions of outcome (r = 0.72) also trended towards an accuracy advantage over the ICH score (p = 0.09) and FUNC score (p = 0.03). In an analysis that excluded patients for whom comfort care was recommended, the 65 available attending physician predictions retained greater accuracy (r = 0.73) than either the ICH score (r = 0.50, p = 0.02) or the FUNC score (r = 0.42, p = 0.004). CONCLUSIONS: Early subjective clinical judgment of physicians correlates more closely with 3-month outcome after ICH than prognostic scales.

Health networks: Actors, professional relationships, and controversies

In recent years international policies have aimed to stimulate the use of information and communication technologies (ICT) in the field of health care. Belgium has also been affected by these developments and, for example, health electronic regional networks ("HNs") are established. Thanks to a qualitative case study we have explored the implementation of such innovations (HN) to better understand how health professionals collaborate through the HN and how the HN affect their relationships. Within the HNs studied a common good unites the actors: the continuity of care for a better quality of care. However behind this objective of continuity of care other individual motivations emerge. Some controversies need also to be resolved in order to achieve cooperative relationships. HNs have notably to take national developments into account. These developments raise the question of the control of medical knowledge and medical practice. Professional issues, and not only practical changes, are involved in these innovations. © 2008 The authors and IOS Press. All rights reserved.

Computer aided parallelisation tools (CAPTools) — conceptual overview and performance on the parallelisation of structured mesh codes

Computer Aided Parallelisation Tools (CAPTools) is a toolkit designed to automate as much as possible of the process of parallelising scalar FORTRAN 77 codes. The toolkit combines a very powerful dependence analysis together with user supplied knowledge to build an extremely comprehensive and accurate dependence graph. The initial version has been targeted at structured mesh computational mechanics codes (eg. heat transfer, Computational Fluid Dynamics (CFD)) and the associated simple mesh decomposition paradigm is utilised in the automatic code partition, execution control mask generation and communication call insertion. In this, the first of a series of papers [1–3] the authors discuss the parallelisations of a number of case study codes showing how the various component tools may be used to develop a highly efficient parallel implementation in a few hours or days. The details of the parallelisation of the TEAMKE1 CFD code are described together with the results of three other numerical codes. The resulting parallel implementations are then tested on workstation clusters using PVM and an i860-based parallel system showing efficiencies well over 80%.

An automatable generic strategy for dynamic load balancing in parallel structured mesh CFD codes

Parallel computing is now widely used in numerical simulation, particularly for application codes based on finite difference and finite element methods. A popular and successful technique employed to parallelize such codes onto large distributed memory systems is to partition the mesh into sub-domains that are then allocated to processors. The code then executes in parallel, using the SPMD methodology, with message passing for inter-processor interactions. In order to improve the parallel efficiency of an imbalanced structured mesh CFD code, a new dynamic load balancing (DLB) strategy has been developed in which the processor partition range limits of just one of the partitioned dimensions uses non-coincidental limits, as opposed to coincidental limits. The ‘local’ partition limit change allows greater flexibility in obtaining a balanced load distribution, as the workload increase, or decrease, on a processor is no longer restricted by the ‘global’ (coincidental) limit change. The automatic implementation of this generic DLB strategy within an existing parallel code is presented in this chapter, along with some preliminary results.

Automatic and effective multi-dimensional parallelisation of structured mesh based codes

The most common parallelisation strategy for many Computational Mechanics (CM) (typified by Computational Fluid Dynamics (CFD) applications) which use structured meshes, involves a 1D partition based upon slabs of cells. However, many CFD codes employ pipeline operations in their solution procedure. For parallelised versions of such codes to scale well they must employ two (or more) dimensional partitions. This paper describes an algorithmic approach to the multi-dimensional mesh partitioning in code parallelisation, its implementation in a toolkit for almost automatically transforming scalar codes to parallel form, and its testing on a range of ‘real-world’ FORTRAN codes. The concept of multi-dimensional partitioning is straightforward, but non-trivial to represent as a sufficiently generic algorithm so that it can be embedded in a code transformation tool. The results of the tests on fine real-world codes demonstrate clear improvements in parallel performance and scalability (over a 1D partition). This is matched by a huge reduction in the time required to develop the parallel versions when hand coded – from weeks/months down to hours/days.

Absence makes the professional try harder? Meeting the needs of socially excluded young men who become fathers

Research on socially excluded young fathers has been minimally addressed in the literature (SEU 1999, 2004). Indeed, research on young parents which informs health and social care professionals is often presented ‘through the eyes of the mother’ (Reeves 2006). Young parents in general and young fathers in particular are notoriously difficult to gain access to and engage with (Tyrer et al 2005) particularly if they have had previous negative involvement with the statutory services. Moreover, as Daniel and Taylor (1999, 2001, 2003) point out, professionals working in the health and care services often have an intense ‘maternal’ focus and this often excludes fathers from discussion and decisions about their children. The focus of this paper, drawing on two narrative studies of young fathers aged between 15-24 from the US and USA, is to evaluate the features of professional relationships that young fathers describe as finding helpful. Indeed, the findings discuss moving away from a culture of parenting classes, which all the young men interviewed described as finding problematical and in some cases embarrassing, to a culture of support which actively draws on their strengths and helps them become providers for their new families.

Continuing Professional Development: rhetoric and practice in the NHS

This article explores the experience of Continuing Professional Development (CPD) by supervisory-level clinical staff in the National Health Service. Four main themes are highlighted in the literature, namely the nature and experience of CPD, its relationship with human resource management practices and in particular in career development and planning. These themes are examined utilising sources of (triangulated) empirical data based on a 2500 sample survey conducted across five NHS Trusts. A key finding was that responsibility for learning and development was perceived as belonging to the individual rather than the organisation. Other findings concern a lack of resource-based commitment by the organisation to CPD for clinical staff undertaking supervisory-level roles and evidence of 'credentialism' with its emphasis on seeking certificated qualifications. The findings raise concerns about the potential for clinical staff to become disillusioned and to perceive a potential breach in their psychological contract because of problems in reconciling their own interests with those of their professional body, and that of their employer in relation to CPD.