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High-quality medical research requires that equipment has been validated for accuracy
James E Sharman1, Wojciech Kosmala2
1Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.
Abstract:
It is not always appreciated that medical equipment may be cleared by regulatory authorities to sell within a country, without ever having been tested for accuracy performance according to scientific validation standards. Instead, manufacturers can undertake in-house accuracy testing, using variable methods and without any requirement for test results to be made publicly available. This lack of full transparency together with potential for industry bias can place doubt over the quality of validation results provided to regulatory authorities. Currently, this situation affects the field of hypertension research, where most blood pressure devices have not been independently validated for accuracy according to international scientific standards, nor as expected in clinical practice guidelines. More attention should be paid to such practices in order to improve the quality of research and to optimize further translation of scientific findings to clinical practice. The clinical implications of inaccurate measurements in research can be far-reaching, ultimately impacting on a patient's health. Well-planned validating studies should be more widely considered for new devices that are candidates to be used in research protocols. The awareness of the lack or uncertain validation of equipment used for verifying research hypotheses should prompt all investigators to revisit the idea of conducting the study or, at least, to acknowledge this issue as a relevant study limitation. One of the ways in which authors submitting research findings for publication can add to the quality of the reporting of their work is to ensure reference to the accuracy validation of their research equipment.
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