One of the roles of the Summary of Product Characteristics (SmPC) is to provide information for health professionals. The objective of this work was to understand the effectiveness of the SmPC document in communicating essential information to prescribers. The process of user testing, widely used to test information for patients, was applied. First, 30 general practitioners were involved in the testing of the SmPC for Lariam, an antimalarial drug. As user testing is an iterative process, 15 points of information in the original SmPC were tested in 3 rounds of 10 participants. The document was revised between rounds according to the results; good practice in information writing and design was used. Next, the SmPC for CellCept, an immunosuppressant, was tested in 20 senior hospital doctors. Again, the document was revised between rounds, according to the results, with revisions also taking account of findings from the Lariam testing related to the general structure of SmPCs. Of the 15 points of information tested, for the original Lariam SmPC, 6 points of information met the target of 90% to find, and 90% of those to understand, whereas for the final version of the CellCept SmPC, 11 points of information met this target. Qualitative comments showed that in their current format, SmPCs are of low perceived value to prescribers and are not central to the clinicians' prescribing behavior. Current content and presentation of SmPCs, while meeting regulatory approval standards, contribute little to the safe and effective use of medication in practice. Key recommendations include revising and simplifying the heading structure and making the headings more visible, adding a "Key Information" summary at the start, using simpler language, and adding bullet points for listings.

ObjectivesApply ‘user testing’ methodology to test the readability of a European Public Assessment Report (EPAR) summary—which describes how the decision was made by the European Medicines Agency to approve a medicine.DesignUser testing uses mixed methods (questionnaire and semistructured interview), applied iteratively, to assess document performance—can people find and understand key points of information.Setting and participantsTesting was undertaken with 40 members of the public in four consecutive rounds of 10. Inclusion criteria, matched across rounds, included range of ages and educational attainment.Tested documentsIn round 1 we tested 19 key points of information in a printed version of the EPAR summary for Bondronat (a cancer medicine). This was then revised to address the findings, and tested in round 2. In round 3 we tested the summary on-screen, and in round 4, tested a revised on-screen version, after addressing findings from both rounds 1 and 3.Primary outcome measureThe target followed European guidance for medicine leaflets: for each point of information 90% of participants should be able to find, and of those, 90% able to show understanding of the point.ResultsFor the original EPAR summary, 6 of the 19 points of information reached the target (both paper-based and on-screen). After revisions to format and content, using good practice in information writing and design, 14 and 16 points, respectively, met the target. The problems related to both finding (dependent on layout, headings and design) and understanding (words and sentences used, as well as design). We devised a new heading structure, increased use of bullet points, replaced difficult and technical words and divided long sentences.ConclusionsPeople had difficulty finding and understanding key messages in the summary, but user testing identified the problems, and application of good practice resulted in a revised format which performed well.

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This paper is concerned with addressing the problems experienced with the thermo-elastic behaviour of the disc -that of optimum heat dissipation, and equally important, even heating of the disc blade. The primary objective is to develop a more temperature-stable brake disc.The work presented approaches the problems of thermal judder through benchmarking the current situation. This is approached by modelling the current brake and its validation by means of vehicle and laboratory testing. The empirical work is centred on a bespoke high speed brake dynamometer which incorporates the full vehicle suspension for an accurate yet controlled simulation of brake and vehicle operating conditions. The dynamometer is housed in a purpose built laboratory with both CCTV and direct visual access. It is capable of dynamic measurement of DTV, caliper pressure fluctuations, disc surface temperature and vibration measurements at discrete points about the rig. This information is presented and supported by thermal imaging of the brake during a heavy brake application and subsequent thermal judder. The results also include surface scanning of the disc which is carried out at appropriate stages during testing to identify disc deformation including disc warping, "ripple" and the effects of "hot spotting".Disc run-out measurements via non-contacting displacement transducers show the disc taking up varying orders of deformation ranging from first to third order during high speed testing. The state of cold deformation of the disc is also shown to vary with the disc returning to first or second order deformation upon cooling.Thermal images of the brake disc have shown vane patterns to show through to the disc surface identifying uneven heat distribution.

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