The Objective Structured Clinical Examination (OSCE): AMEE Guide No. 81. Part II: organisation & administration.

The organisation, administration and running of a successful OSCE programme need considerable knowledge, experience and planning. Different teams looking after various aspects of OSCE need to work collaboratively for an effective question bank development, examiner training and standardised patients' training. Quality assurance is an ongoing process taking place throughout the OSCE cycle. In order for the OSCE to generate reliable results it is essential to pay attention to each and every element of quality assurance, as poorly standardised patients, untrained examiners, poor quality questions and inappropriate scoring rubrics each will affect the reliability of the OSCE. The validity will also be influenced if the questions are not realistic and mapped against the learning outcomes of the teaching programme. This part of the Guide addresses all these important issues in order to help the reader setup and quality assure their new or existing OSCE programmes.

The Objective Structured Clinical Examination (OSCE): AMEE Guide No. 81. Part I: an historical and theoretical perspective.

The Objective Structured Clinical Examination (OSCE) was first described by Harden in 1975 as an alternative to the existing methods of assessing clinical performance (Harden et al. 1975). The OSCE was designed to improve the validity and reliability of assessment of performance, which was previously assessed using the long case and short case examinations. Since then the use of the OSCE has become widespread within both undergraduate and postgraduate clinical education. We recognise that the introduction of the OSCE into an existing assessment programme is a challenging process requiring a considerable amount of theoretical and practical knowledge. The two parts of this Guide are designed to assist all those who intend implementing the OSCE into their assessment systems. Part I addresses the theoretical aspects of the OSCE, exploring its historical development, its place within the range of assessment tools and its core applications. Part II offers more practical information on the process of implementing an OSCE, including guidance on developing OSCE stations, choosing scoring rubrics, training examiners and standardised patients and managing quality assurance processes. Together we hope these two parts will act as a useful resource both for those choosing to implement the OSCE for the first time and also those wishing to quality assure their existing OSCE programme.

Conceptual framework for performance assessment: competency, competence and performance in the context of assessments in healthcare--deciphering the terminology.

BACKGROUND: The definitions of performance, competence and competency are not very clear in the literature. The assessment of performance and the selection of tools for this purpose depend upon a deep understanding of each of the above terms and the factors influencing performance. AIM: In this article, we distinguish between competence and competency and explain the relationship of competence and performance in the light of the Dreyfus model of skills acquisition. We briefly critique the application of the principles described by Miller to the modern assessment tools and distinguish between assessment of actual performance in workplace settings and the observed performance, demonstrated by the candidates in the workplace or simulated settings. RESULTS: We describe a modification of the Dreyfus model applicable to assessments in healthcare and propose a new model for the assessment of performance and performance rating scale (PRS) based on this model. CONCLUSION: We propose that the use of adapted versions of this PRS will result in benchmarking of performance and allowing the candidates to track their progression of skills in various areas of clinical practice.

Implications for sequencing of biologic therapy and choice of second anti-TNF in patients with inflammatory bowel disease: results from the IMmunogenicity to Second Anti-TNF therapy (IMSAT) therapeutic drug monitoring study.

BACKGROUND: Anti-drug antibodies are associated with treatment failure to anti-TNF agents in patients with inflammatory bowel disease (IBD). AIM: To assess whether immunogenicity to a patient's first anti-TNF agent would be associated with immunogenicity to the second, irrespective of drug sequence METHODS: We conducted a UK-wide, multicentre, retrospective cohort study to report rates of immunogenicity and treatment failure of second anti-TNF therapies in 1058 patients with IBD who underwent therapeutic drug monitoring for both infliximab and adalimumab. The primary outcome was immunogenicity to the second anti-TNF agent, defined at any timepoint as an anti-TNF antibody concentration ≥9 AU/ml for infliximab and ≥6 AU/ml for adalimumab. RESULTS: In patients treated with infliximab and then adalimumab, those who developed antibodies to infliximab were more likely to develop antibodies to adalimumab, than patients who did not develop antibodies to infliximab (OR 1.99, 95%CI 1.27-3.20, p = 0.002). Similarly, in patients treated with adalimumab and then infliximab, immunogenicity to adalimumab was associated with subsequent immunogenicity to infliximab (OR 2.63, 95%CI 1.46-4.80, p < 0.001). For each 10-fold increase in anti-infliximab and anti-adalimumab antibody concentration, the odds of subsequently developing antibodies to adalimumab and infliximab increased by 1.73 (95% CI 1.38-2.17, p < 0.001) and 1.99 (95%CI 1.34-2.99, p < 0.001), respectively. Patients who developed immunogenicity with undetectable drug levels to infliximab were more likely to develop immunogenicity with undetectable drug levels to adalimumab (OR 2.37, 95% CI 1.39-4.19, p < 0.001). Commencing an immunomodulator at the time of switching to the second anti-TNF was associated with improved drug persistence in patients with immunogenic, but not pharmacodynamic failure. CONCLUSION: Irrespective of drug sequence, immunogenicity to the first anti-TNF agent was associated with immunogenicity to the second, which was mitigated by the introduction of an immunomodulator in patients with immunogenic, but not pharmacodynamic treatment failure.