Competency Assessment of General Surgery Trainees: A Perspective From the Global South, in a CBME-Naive Context.

OBJECTIVE: Before proceeding with local implementation of competency-based medical education-related assessment practices designed and evaluated in the Global North, we sought to challenge the assumption that this would be perceived as both necessary and acceptable in our context where training and assessment is based on a traditional, knowledge-focused approach. The aim of this study was to determine the perspectives of general surgery trainees and consultants towards the assessment of competence, how this has been achieved previously, and how it should be performed in the future at the University of Cape Town (UCT), South Africa. DESIGN: Semi-structured interviews were conducted with consultants and trainees. Interviews were transcribed and then analyzed using a Reflexive Thematic Analysis approach. SETTING AND PARTICIPANTS: Ten consultants (5 senior and 5 junior) and 10 trainees (5 South African and 5 international) from the Division of General Surgery at UCT in August 2022. RESULTS: Five unique themes were developed: (1) Assessment of competence is essential, (2) competence includes multiple domains of practice, (3) a surgeon must be able to operate, (4) previously used methods were inadequate to assess competence, and (5) frequent assessment with feedback is desired. The themes were considered in the context of Situated Learning Theory, particularly Communities of Practice and their role in the training for, and authentic assessment of, competence in general surgery trainees. CONCLUSIONS: Participants described a need to develop and implement a new competency assessment program for general surgery training in this context, which is aligned with described competency-based medical education principles. Thoughtful integration of the formative and summative use of direct observation in the workplace, with a clear emphasis on procedural ability and the provision of high-quality feedback, may enhance the successful implementation of a strategy for competency-based assessment in general surgery training programs.

Why commercialization of gene therapy stalled; examining the life cycles of gene therapy technologies.

This report examines the commercialization of gene therapy in the context of innovation theories that posit a relationship between the maturation of a technology through its life cycle and prospects for successful product development. We show that the field of gene therapy has matured steadily since the 1980s, with the congruent accumulation of >35 000 papers, >16 000 US patents, >1800 clinical trials and >$4.3 billion in capital investment in gene therapy companies. Gene therapy technologies comprise a series of dissimilar approaches for gene delivery, each of which has introduced a distinct product architecture. Using bibliometric methods, we quantify the maturation of each technology through a characteristic life cycle S-curve, from a Nascent stage, through a Growing stage of exponential advance, toward an Established stage and projected limit. Capital investment in gene therapy is shown to have occurred predominantly in Nascent stage technologies and to be negatively correlated with maturity. Gene therapy technologies are now achieving the level of maturity that innovation research and biotechnology experience suggest may be requisite for efficient product development. Asynchrony between the maturation of gene therapy technologies and capital investment in development-focused business models may have stalled the commercialization of gene therapy.

Tuberculosis screening in prescribers of anti-tumor necrosis factor therapy in the European Union.

SETTING: Physician offices and hospital-based settings in 24 European Union countries. OBJECTIVES: To assess the awareness of tuberculosis (TB) risk, performance of TB screening and factors predicting TB screening among prescribers of tumor necrosis factor alpha (TNF-α) agents. METHODS: A total of 915 prescribers (441 rheumatologists, 266 gastroenterologists and 208 dermatologists) of anti-TNF agents participated in a 41-item survey between March and May 2010. Multivariate analyses were conducted to identify predictors of TB screening. RESULTS: Overall, ≥88% of physicians identified TB reactivation as an adverse effect associated with anti-TNF use. Self-reported TB screening ranged from 73% of gastroenterologists in the five foremost industrialized economies (G5) countries to 92% of rheumatologists in non-G5 countries. Factors predictive of TB screening included rheumatology or gastroenterology specialty, higher awareness of TB reactivation as a risk, greater adherence to TB testing guidelines, larger caseloads of patients with severe disease, practicing in a major industrialized country and greater number of anti-TNF agents for which risk-related information had been received. CONCLUSIONS: Most physicians reported being aware of the attendant risk for reactivation of latent TB infection with anti-TNF treatments. Results suggest that distributing pertinent educational materials is an effective component of a risk minimization strategy to promote TB screening among anti-TNF prescribers.

Broad spectrum antimicrobial activity of a new multi-purpose disinfecting solution.

PURPOSE: There has been increasing awareness of the need for more powerful contact lens disinfectants, ideally having low toxicity and allergenicity to ocular tissue. Opti-Free Express with ALDOX Multi-Purpose Disinfecting Solution (MPDS) was recently marketed as a new multi-purpose disinfecting solution for soft contact lenses. MPDS contains two antimicrobial agents, polyquaternium-1 and myristamidopropyl dimethylamine, to broaden the range of antimicrobial activity. The purpose of this study was to evaluate the antimicrobial activity of MPDS against microorganisms that have been reported as contact lens and lens case contaminants and causative agents of microbial keratitis. METHODS: MPDS was challenged with high numbers of gram-positive and gram-negative bacteria, yeast, mold, and Acanthamoeba. Several lots of product were challenged with at least three separate inocula of each isolate. After exposure to the disinfecting solution, a sample was removed from the product and plated for survivors by suitable recovery methods. The plates were incubated and the number of survivors was enumerated. RESULTS: The results showed that MPDS was bactericidal, fungicidal and amoebicidal against an extensive variety of environmental contaminants of lens care accessories and ocular pathogens. MPDS was capable of killing a broad spectrum of microorganisms. The log reduction exceeded the primary criteria for disinfecting products and produced a notable reduction of other clinical and environmental isolates as well. CONCLUSIONS: Opti-Free Express MPDS contains antimicrobial agents that can kill an extensive spectrum of many different types of microorganisms that may contaminate contact lenses and solutions.

Notification of real-time clinical alerts generated by pharmacy expert systems.

We developed and implemented a strategy for notifying clinical pharmacists of alerts generated in real-time by two pharmacy expert systems: one for drug dosing and the other for adverse drug event prevention. Display pagers were selected as the preferred notification method and a concise, yet readable, format for displaying alert data was developed. This combination of real-time alert generation and notification via display pagers was shown to be efficient and effective in a 30-day trial.

Scaling an expert system data mart: more facilities in real-time.

Clinical Data Repositories are being rapidly adopted by large healthcare organizations as a method of centralizing and unifying clinical data currently stored in diverse and isolated information systems. Once stored in a clinical data repository, healthcare organizations seek to use this centralized data to store, analyze, interpret, and influence clinical care, quality and outcomes. A recent trend in the repository field has been the adoption of data marts--specialized subsets of enterprise-wide data taken from a larger repository designed specifically to answer highly focused questions. A data mart exploits the data stored in the repository, but can use unique structures or summary statistics generated specifically for an area of study. Thus, data marts benefit from the existence of a repository, are less general than a repository, but provide more effective and efficient support for an enterprise-wide data analysis task. In previous work, we described the use of batch processing for populating data marts directly from legacy systems. In this paper, we describe an architecture that uses both primary data sources and an evolving enterprise-wide clinical data repository to create real-time data sources for a clinical data mart to support highly specialized clinical expert systems.

Production, characterisation and use of monoclonal antibodies to human interleukin-5 in an enzyme-linked immunosorbent assay.

Two mouse monoclonal antibodies (Mabs) against recombinant human interleukin-5(rhIL-5) have been produced, characterised and purified. Both are IgG1 antibodies and neutralised the activity of rhIL-5 in the B13 assay. Neither Mab cross-reacted with mouse IL-5. A two-site sandwich enzyme-linked immunosorbent assay (ELISA) was developed with different combinations of the mouse Mabs and also a rat anti-mouse IL-5 Mab, TRFK5, which also has activity against rhIL-5. The most sensitive assay, with a lower detection limit of 0.5 ng/ml IL-5, used TRFK5 as the capture antibody and the mouse anti-human IL-5 Mab as second antibody. The sensitivity of this assay was increased by an enhanced chemiluminescent reagent and resulted in a lower limit of detection around 40 pg/ml IL-5.

Functional and phenotypic analysis of human T-cell clones which stimulate IgE production in vitro.

Peripheral blood mononuclear cells (PBMC) from a patient suffering from the hyper IgE syndrome were used to generate phytohaemagglutinin (PHA)-expanded T-cell clones (all CD4+, CD8-, CD23-). A selection of the clones was tested for their ability to help IgE secretion by culturing with normal B cells in the presence of solid-phase antibody to CD3. Supernatants were harvested on Day 7 and assayed by ELISA for IgE, IgG and IgM. Lymphokine secretion by the clones was assessed by culturing clones for 24 hr with solid-phase antibody to CD3 followed by assay of the supernatants for IL-2, IL-4 and interferon-gamma (IFN-gamma) production. In addition, clones were analysed by flow cytometry for CDw29 and CD45R expression. Initial experiments with seven clones indicated that those clones that could help IgE secretion also stimulated optimal IgG and IgM responses. All clones appeared to secrete IL-2, IL-4 and IFN-gamma, although the amounts of each varied. These results confirm recent findings that human T-cell clones do not fall into Tinf (Th1) and Th (Th2) type subsets as described in the mouse. There was no clear correlation between the lymphokines secreted by the clones and their capacity to help IgE production. However, the helper function of the clones for all isotypes, including IgE, appeared to be related to the level of expression of the surface antigen CDw29.