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CACHET Unified Methodology for Assessment of Clinical Feasibility

This technical report describes the CACHET Unified Methodology for Assessment of Clinical Feasibility (CUMACF). The purpose of this methodology is to provide a standardized way across CACHET projects to assess `clinical feasibility' of the technologies that are being designed and tested. 

From a health-oriented perspective, a carefully designed Randomised Clinical Trials (RCT) which minimises the possibility of bias has become accepted as the `gold standard' for determining the effectiveness of pharmacological agents, and this approach has been transferred to evaluating non-pharmacological interventions, including health technology. However, the traditional RCT approach has a set of limitations for evaluating health technology, including the fact that the RCT does not permit iterative improvements to the design and that the technology may be outdated by the time the trial is complete.

Despite the different scientific paradigms and methodological approaches between the design sciences and health sciences, there is a growing need to be able to design and develop health technologies while being able to point to health benefits - in particular in the early stages of technology development and evaluation. For this purpose, we propose the CACHET Unified Methodology for Assessment of Clinical Feasibility (CUMACF) approach. The goal of CUMACF is to help researchers in the process of designing and developing health technology to run what we have chosen to call feasibility studies, i.e. studies that help understand whether the technology under design would be feasible to use in future health interventions, if implemented in full scale. 

Cook Book

This technical report is a `cook book' for CUMACF. The report describes the CUMACF method, which focuses on assessing three things;

  1. usage adoption
  2. perceived usefulness and usability
  3. health efficacy.

The report also provides guidelines for how to analyze and visualize the data being collected. Finally, the report contains a set of appendices providing references to concrete questionnaires and R scripts for doing data analysis and visualizations. 

The overall objective of CUMACF is to provide a standardized way to assess the `feasibility' of a health technology during design and development. Such a standardized method will help to compare test results both within the iterative design of one specific technology as well as between different technologies. The former implies that a design team can assess the progression of their design across multiple iterations of the technology, whereas the latter implies that different technologies - maybe targeting the same health outcome - can be evaluated and compared in a more standardized manner. 

Reference

  • Jakob E. Bardram.CACHET Unified Methodology for Assessment of Clinical Feasibility. Technical report. Copenhagen, Denmark: Copenhagen Center for Health Technology, 2018. Available from http://www.cachet.dk/research/cumacf [pdf]

 

 
http://www.cachet.dk/research/cumacf
17 DECEMBER 2018