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In spite of their different aims, evidence-based medicine (EBM) and health technology assessment (HTA) to some extent use similar methodologies for the assessment of a technology's efficacy. The decision to include only a certain quality of studies in a HTA report usually follows the hierarchy of evidence with different levels of evidence. Problems arise if study evidence is completely lacking or if it is extrapolated or transferred to other healthcare settings. As subjectivity is inevitable when critically appraising the evidence or combining it with other sources of information, HTA decisions should be presented with maximum transparency. Since physicians usually have only limited knowledge of research methodology and read only an average of 20 articles per year, a cooperative approach is required when appraising the evidence for HTA.
This paper recognizes that Biomedical Engineering is a changing field affecting Biomedical Engineering curricula developers, investors and manufacturers in Australia. It reports on some of the attitudes of senior Biomedical Engineers to future developments in Biomedical Engineering in Australia.
This paper examines the role of evaluation in the design of health care information systems. A framework is presented for considering evaluation in the context of software development processes, in particular, the systems development life cycle (SDLC). Variations on standard design methodologies are then discussed, including methods based on rapid development and continual evaluation of prototype systems. Usability testing is presented as a key method for conducting evaluations during iterative system development. The emergence of design methodologies, where evaluation is viewed as a central part of the development cycle is also discussed. Evaluation methodologies are then considered along a continuum, ranging from studies involving a high degree of experimental control to observational approaches. A full cycle approach to evaluation of health care systems is argued for, involving deployment of new methods across the SDLC. Implications for future work exploring the integration of design and evaluation processes in health informatics are discussed.
Economic and policy issues increasingly influence healthcare technology solutions as we wrestle with keeping healthcare quality high while keeping costs under control. The healthcare system is also undergoing rapid change brought about by managed care, shifting care to team providers in an outpatient or home environment. The development of health technologies under new market arrangements needs to be examined so that quality of care and cost are not at cross roads. As these issues continue to evolve in the public forum, it is critical for engineers and contributors to technology in healthcare to understand the dynamics that influence technology need and and adoption in the healthcare market. We hope that this special issue will provide a basis for initial understanding of these issues and stimulate further involvement by the bioengineering community at large, for the improvement of healthcare across all of society.
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The potential medical applications of microarrays have generated much excitement, and some skepticism, within the biomedical community. Some researchers have suggested that within the decade microarrays will be routinely used in the selection, assessment, and quality control of the best drugs for pharmaceutical development, as well as for disease diagnosis and for monitoring desired and adverse outcomes of therapeutic interventions. Realizing this potential will be a challenge for the whole scientific community, as breakthroughs that show great promise at the bench often fail to meet the requirements of clinicians and regulatory scientists. The development of a cooperative framework among regulators, product sponsors, and technology experts will be essential for realizing the revolutionary promise that microarrays hold for drug development, regulatory science, medical practice and public health.
Recent developments in biomedical informatics research have afforded possibilities for great advances in health care delivery. These exciting opportunities also present a number of challenges to the implementation and integration of technologies in the workplace. As in most domains, there is a gulf between technologic artifacts and end users, which compromises the culture of safety in the workplace. Because clinical practice is a human endeavor, there is a need for bridging disciplines to enable clinicians to benefit from rapid technologic advances. This, in turn, necessitates a broadening of disciplinary boundaries to consider cognitive and social factors related to the design and use of technology. The authors argue for a place of prominence for cognitive science in understanding nursing factors associated with patient safety. Cognitive science provides a framework for the analysis and modeling of complex human performance. Studies of clinical cognition can meaningfully inform and shape design, development and assessment of information systems. Furthermore, they have a decisive impact on whether information technology has a positive influence on human performance and are especially important in understanding and promoting safe practices. These issues are discussed in the context of clinical informatics with a focus on nursing practice.
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If a demand exists for the evaluation of the favourable and adverse effects of a medical procedure, a comparison is required; this comparison should be fair. The only procedure that ensures a fair comparison is randomisation. Randomised controlled trials (RCTs) therefore represent the gold standard in the evaluation of medical procedures; the non-application of a randomisation process must be justified in detail in individual cases. Reasons presented for not conducting an RCT are mainly based on a misunderstanding of the term "randomisation". They may also be based on circumstances where the conduct of any simultaneous comparison is unsuitable (independent of the mode of allocation) or on situations where there is practically no hypothesis available for a comparison, or even for a study. These factors are taken into account by the current regulations valid in Germany on the approval of drugs and on the reimbursement eligibility of health care services by statutory health insurance.
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Medical technologies move from research and development through manufacturing and marketing into the healthcare delivery system. Within the healthcare delivery system, hospitals rely heavily on medical technologies (and the medical devices they enable) to provide diagnosis, treatment, and monitoring in patient care. Managing these devices from acquisition through application in patient care is a formidable task. Hospitals must act to maximize the benefits of medical devices while minimizing adverse side effects. They must do so within a highly regulated and cost-constrained environment. This paper describes the challenges hospitals face and the strategies they employ in their efforts to achieve cost-effective medical technology management. The role of clinical engineering is discussed.
How health care should be reformed to address the current economic pressures and deliver a better future.