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The usefulness and effectiveness of specific serious games in the medical domain is often unclear. This is caused by a lack of supporting evidence on validity of individual games, as well as a lack of publicly available information. Moreover, insufficient understanding of design principles among the individuals and institutions that develop or apply a medical serious game compromises their use. This article provides the first consensus-based framework for the assessment of specific medical serious games. The framework provides 62 items in 5 main themes, aimed at assessing a serious game’s rationale, functionality, validity, and data safety. This will allow caregivers and educators to make balanced choices when applying a serious game for healthcare purposes. Furthermore, the framework provides game manufacturers with standards for the development of new, valid serious games.
Although results for serious games in terms of effectiveness for such purposes are promising, their implementation as “serious” modalities for prevention, treatment, or training in health care is hindered by lack of understanding of the underlying concepts among health care professionals, or even distrust. Before doctors and patients consider using serious games as a useful solution for a health care-related problem, it is important that they understand what problem is being addressed by the game and that a proposed claim on effectiveness is indeed trustworthy. Many clinicians are currently undereducated in judging a serious game’s safety or effectiveness. Information on individual games is often hard to find in disorganized app stores and websites [
This article discusses the first tool for the systematic assessment of serious games applied to medical use, for educators and clinicians. The information collected and organized accordingly, will aid health care practitioners to understand and appraise the risks and benefits of specific serious games in health care in a uniform manner.
To our knowledge, there is currently no systematic framework for the assessment of serious games in health care described in literature. Therefore, the Dutch Society for Simulation in Healthcare (DSSH) [
The panel reviewed the items from these reporting standards during two meetings. All items in the Albrecht framework [
The framework described provides 62 items in 5 main themes (
Items relevant for the assessment of a serious game used for health care-related purposes.
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Category | Item | Question |
Game description | Meta-data | Operating system | Operating systems of the game |
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Version | Version | |
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Web-link | Web-link | |
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Project type | Commercial, non-commercial, other | |
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Access | Public / restricted / other | |
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Adjunct devices | Is an adjunct device needed? | |
Development | Funding | How was development funded? Eg, funding agencies, investors | |
Sponsoring / Advertising | Advertisement policy | Is the game free of commercial pop-ups? | |
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If not, what is advertised? | |
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Sources of income | Are there sources of income within the game? | |
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Sources of income outside game | What are the sources of income of the owner/distributor? | |
Potential conflicts of interest | Affiliations | What affiliations do the publishers have that could influence content or user group? | |
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Conflicts of interest | What interests do the publishers have that could influence the game’s content or user group? | |
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Disclosure | Are conflicts of interest disclosed? | |
Rationale | Purpose | Goal or purpose | What is (are) the purpose(s) of the game? |
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Disclosure | Is (are) the purpose(s) disclosed to users? | |
Medical device | Medical device | Is the serious game a medical device, or not? | |
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Class | If yes, which class? | |
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Approval by legal bodies | If yes, does it comply to the necessary requirements (FDA-approval, CE-mark?). | |
User group | Specific user groups | For each user group: disease/condition, or health care profession. | |
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Description | Please specify gender, age (range), and other relevant descriptive items. | |
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Limits | Are there age limits, or other limits? | |
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Disclosure | Is the intended user group disclosed? | |
Setting | Patient care | Is the game used in patient care? | |
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Training courses | Is the game used in training courses or -curricula? | |
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SCORM compliancy | If used in training courses or curricula, is the serious game SCORM-compliant? | |
Functionality | Purposes / didactic features | For every purpose of the game: |
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Learning or behavioral goals | What content will the player learn? | |
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Relation learning and gameplay | How does the learning content relate to the gameplay? | |
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Instruction | What intervention leads to the learning transition (eg, tutorial, instructions (in-game)) | |
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Assessment (progress) in game | Through which parameters is progress in the game measured? | |
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Assessment parameters | Which parameters are to designers' opinion indicative for measuring learning effects? | |
Content Management | Content Management system | Is the Content Management System restricted to specified persons or institutions? | |
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User uploaded content | If no, are users allowed to upload their own content? | |
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Content monitoring | How is uploaded content checked? | |
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Restrictions and limits of the serious game | Please describe restrictions and limits of the serious game. What content on the learning goals is not covered? | |
Potentially undesirable effects | Potentially undesirable effects | What potential undesirable effects could the game have? | |
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Disclosure | Are such potential undesirable effects disclosed to the user? | |
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Measures taken | What measures are taken to prevent potential undesirable effects? | |
Validity | Design process | Medical expert complicity | Were medical experts (content experts) involved in the design process from the start? |
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User group complicity | Were representatives from the user group involved in the design process from the start? | |
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Educationalist complicity | Were educationalists involved in the design process from the start? | |
User testing | User testing | Did user testing take place? What were the results, and how were these incorporated in the design? | |
Stability | Platform stability | Does the game produce the same results on different platforms? | |
Validity (effectiveness) | Face validity | Do educators and trainees view it as a valid way of instruction? | |
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Content validity | How is its content validated to be complete, correct, and nothing but the intended medical construct? | |
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Construct validity | Is the game able to measure differences in skills it intends to measure? | |
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Concurrent validity | How does learning outcome compare to other methods assessing the same medical construct? | |
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Predictive validity | Does playing the game predict skills improvement in real life? | |
Data protection | Data protection and privacy | Data processing | How is data collected in the serious game? |
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Patient privacy | Are patient-specific data stored in the game? | |
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If yes, are patient informed consent criteria met according to relevant national standards? | ||
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Data ownership | Who owns and stores the data resulting from play? | |
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Data storage period | During what period are data stored? | |
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Data removal | Can the user delete data temporarily and/or permanently? | |
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Data storage security | Is the data storage secured in conformity with laws of the countries stated above? | |
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Data transmission security | Is the data transmission secured in conformity with laws of the countries stated above? | |
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Disclosure | Are all items on “data protection” disclosed to the user? |
When evaluating a specific serious game, it should be thoroughly described and registered (including information about the manufacturer or owner to whom the game should be attributed and the version). Equally to mobile applications, a special interest is taken into the owner’s policy concerning revenues from sponsoring and advertisements, both during development as well as its use. Sources of revenue and affiliations (eg, pharmaceutical industry) may bias or threaten a serious game’s validity for obvious reasons. These should be fully disclosed to the game’s users. Sources of income within a game can be equally relevant to the costs required for the initial purchase.
This clarifies the game’s purpose outside the game. This external purpose (eg, improving eye-hand coordination in laparoscopic surgery) may differ from the actual goal
Additionally, serious games might fall within the scope of the medical devices, requiring specific guidelines to be implemented, set by the US Food & Drug Administration (FDA), European Committee (Conformité Européenne
Functionality of a serious game clearly differs from that of an mHealth app. These usually contain “dry” content (eg, medical information) or an obvious functionality (eg, communicating or registering information), whereas a game requires the user to operate or interact with the content, with the ultimate goal to change ones behavior in real life (ie, learning). To understanding this process, information is required on the game’s content, how the instruction is delivered, how performance is assessed and how these aspects are integrated in the gameplay [
Consequently, it is important to register information on the game’s content management. For instance, users may be able to add content themselves, making content validation an important issue. This directly influences the game’s content’s validity.
Finally, undesired results or negative transfer of learning could occur in the interaction with a serious game, which is not the same concept as “gaming the game” (ie, cheating), an effect that may very well enhance learning [
Validity determines whether an instructional instrument (such as a serious game) adequately resembles the construct it aims to educate or measure
Validity research is frequently a long and costly enterprise. Many newly developed serious games have therefore not yet undergone validity research [
Threats to user privacy are imminent in electronic and mobile health apps, especially when patient-specific data are measured or entered in the game [
When using serious games in health care, end users (clinicians, patients, or educators) must decide whether games are safe and effective enough to be used for their intended purposes. In order to do so, they need consistent, transparent, and reliable assessments. Are applied games really stating their claim in this field? In the framework described in this article, both developers and end users are supported in assessing relevance, validity, and data safety of an applied game. In order to become a “qualified game”, developers should disclose comprehensive information on their products and claims. They must provide transparency to meet the standards. The
The safe application of technology-enhanced solution remains the responsibility of the health care provider. Choosing if a serious game answers to the user’s needs, can be based on information concerning 5 main areas described in this article. The majority of the items cannot be assessed using objective parameters. For instance, claiming a specific serious game’s predictive validity should be supported by solid evidence. A comprehensive evaluation by a panel of experts in the form of a quality label could form a more practical solution.
Guidelines have been recently published reporting standards to support clinicians and patients in distinguishing high quality mhealth apps [
There are several limitations to the framework described in this study. It considers validity of the serious game’s content and its didactic functionality. Validity does not predict a game’s success nor its attractiveness to the user, which also depend on its entertainment capability and distribution method [
In summary, this consensus-based tool provides the end users the support required when assessing the effectiveness and relevance of serious games in health care. An FDA-approval or CE-mark is simply insufficient for this purpose. In order to prevent wrongful application and data theft of unsuspecting patients or medical students, this information on medical serious games should become publically available to all end users. This will aid the prescription of safe and effective games to patients and the implementation of games into educational programs.
The authors received funding from the Patient safety project (grant ref PID 101060), of the
The Committee for Serious Gaming committee of the Dutch Society for Simulation in Healthcare (DSSH) consist of the following members: M Graafland (Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands); MEW Dankbaar (Department of Medical Education (Desiderius School), Erasmus University Medical Centre, Rotterdam, The Netherlands); A Mert (National Military Rehabilitation Centre, Doorn, The Netherlands); J Lagro (Department of Geriatrics, Radboud University Medical Centre, Nijmegen, The Netherlands); LD de Wit-Zuurendonk (Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands); SCE Schuit (Departments of Emergency Medicine and Internal Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands); A Schaafstal (Department of ICT, Windesheim University of Applied Sciences, Zwolle, The Netherlands); and MP Schijven (Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands).
None declared.