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“We need a change of mind”
-
Transforming the clinical
evaluation for Games for Health.
Stephanie Jansen-Kosterink, Phd
2
3
4
5
6
Typeofevaluation
7
True potential of Games for Health
8
• To increase the quality of care
• To increase the accessibility of care
• To lower the rise of health care costs
 The type of
evaluation should be
tailored to the
development life cycle
of the game.
 The true potential of
Games for Health can
only be evaluated
when these games
are implemented in
the daily clinical
setting.
9
10
Innovative study designs (1)
• Cohort Multiple Randomized Controlled Trial
11
cmRCT
12
cmRCT
13
Innovative study designs (2)
• Stepped wedge cluster randomized trials
14
SWT
15
16
Thank you!
17

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We need a change of mind – Transforming the clinical evaluation for Games for Health

Editor's Notes

  1. As evidence-based medicine is regarded as a requirement for acceptance of a new treatment, such as Games for Health, it is important to execute proper clinical evaluations to convince professionals, policy makers and insurance companies about its implementation
  2. However, Randomized Controlled Trials RCT) are considered as the gold standard for evaluating the safety and effectiveness of medical interventions. The characteristics of an RCT do not match well with the clinical evaluation of Games for Health. An argument for this is that RCTs are taking a considerable period of time while concurrent Games for Health are rapidly evolving. It takes time to prepare and execute a RCT with sufficient power and this sets a hold on the game development with the consequence that at the beginning of the trial the game is new and at the end of the trial the game is outdated.
  3. Therefore, the aim of this abstract is to provided two golden rules that should be taken into account during the preparation of a proper evaluation for Games for Health.
  4. Focusing on the literature and our experience with the evaluation of other technology supported interventions in a clinical setting we purpose the following two golden rules. Firstly, the type of evaluation should be tailored to the development life cycle of the game. The development of games is an iterative process and starts with the evaluation of new games on an application level and ends with the evaluation of mature games on a global level. End-user should first be able to use the game properly before this game is ready to be evaluated on a global level. Therefore, games can only be evaluated on a global level when the evaluation on an application level is successfully completed. To prevent disappoint outcome only mature technology can be evaluated on a global level.
  5. Secondly, the true potential of Games for Health can only be evaluated when these games are implemented in the daily clinical setting. The added value of games are related to the clinical aim and the way a games is implemented in a daily clinical setting Therefore, the outcomes of the evaluation of games need to relate to the hypothesized added value of the game on beforehand, focusing on accessibility of care, quality of care and costs of care
  6. It is our advised to follow these rules when you are preparing a clinical trial. By following these rules the iterate game development process can be continue during the evaluation, unsatisfactory results are reduces as only mature games can be evaluation on a global level and the true potential of Games for Health can be evaluated as games are implemented in the daily clinical practice.
  7. Off course, to follow these rules the traditional study designs are not sufficient and we have to focus on other designs to evaluate games. Innovative study design such as, cohort multiple randomized controlled trails and stepped wedge cluster randomized trials.
  8. Off course, to follow these rules the traditional study designs are not sufficient and we have to focus on other designs to evaluate games. Innovative study design such as, cohort multiple randomized controlled trails and stepped wedge cluster randomized trials.