Validity and reliability of a wearable-controlled serious game and goniometer for telemonitoring of wrist fracture rehabilitation.

PURPOSE: To determine the validity of wrist range of motion (ROM) measurements by the wearable-controlled ReValidate! wrist-rehabilitation game, which simultaneously acts as a digital goniometer. Furthermore, to establish the reliability of the game by contrasting ROM measurements to those found by medical experts using a universal goniometer. METHODS: As the universal goniometer is considered the reference standard, inter-rater reliability between surgeons was first determined. Internal validity of the game ROM measurements was determined in a test-retest setting with healthy volunteers. The reliability of the game was tested in 34 patients with a restricted range of motion, in whom the ROM was measured by experts as well as digitally. Intraclass-correlation coefficients (ICCs) were determined and outcomes were analyzed using Bland-Altman plots. RESULTS: Inter-rater reliability between experts using a universal goniometer was poor, with ICCs of 0.002, 0.160 and 0.520. Internal validity testing of the game found ICCs of - 0.693, 0.376 and 0.863, thus ranging from poor to good. Reliability testing of the game compared to medical expert measurements, found that mean differences were small for the flexion-extension arc and the radial deviation-ulnar deviation arc. CONCLUSION: The ReValidate! game is a reliable home-monitoring device digitally measuring ROM in the wrist. Interestingly, the test-retest reliability of the serious game was found to be considerably higher than the inter-rater reliability of the reference standard, being healthcare professionals using a universal goniometer. TRIAL REGISTRATION NUMBER: (internal hospital registration only) MEC-AMC W17_003 #17.015.

Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial.

INTRODUCTION: Distal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy. METHODS AND ANALYSIS: To test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment.Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model.Patients are randomised between using the wearable-controlled mobile serious game ReValidate! (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group). ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NTR), NL6140, protocol V.2.

Face Validity and Content Validity of a Game for Distal Radius Fracture Rehabilitation.

Background Patients recovering from a variety of wrist injuries are frequently advised to exercise to regain lost wrist and hand function. Treatment regimens to regain motion in the wrist are highly variable, and adherence to exercise protocols is known to be low. A serious game ReValidate! incorporating standardized exercise regimens was developed to motivate patients. In this study, the game is evaluated regarding its face validity and content validity. Methods In this cross-sectional study, a mixed group of "users" ( n = 53) including patients currently recovering from wrist injury, and a mixed group of "experts" ( n = 46) including professionals advising patients on therapy regimen after wrist injury played at least one complete level of the serious game. Players evaluated the game by means of a structured questionnaire regarding its content, clinical applicability, and user experience. Questions were answered on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Results All groups valued the game as being able to support wrist rehabilitation and being of use to patients recovering from a distal radius fracture (users: median 4, P25-P75 3-4 vs. experts: median 4, P25-P75 3.50-5; p = not significant). The types of exercises performed during the game were considered to be both realistic and complete compared with regular physiotherapy exercises (users: median 4, P25-P75 3-4 vs. experts: median 4, P25-P75 3-5, p = not significant). Conclusions The ReValidate! serious game can be regarded as a valid tool for patients to regain their wrist function after injury. Level of evidence This is a Level II study.

Systematic Review on the Effects of Serious Games and Wearable Technology Used in Rehabilitation of Patients With Traumatic Bone and Soft Tissue Injuries.

OBJECTIVE: To assess the effects on functional outcomes and treatment adherence of wearable technology and serious games (ie, interactive computer applications with specific purposes useful in the "real world") currently used in physical rehabilitation of patients after traumatic bone and soft tissue injuries. DATA SOURCES: PubMed, EMBASE, Cochrane Library, and Current Index to Nursing and Allied Health Literature were searched without publication date restrictions for the terms wearable, serious game, videogame or mobile application, and rehabilitation, exercise therapy, and physiotherapy. STUDY SELECTION: The search yielded 2704 eligible articles, which were screened by 2 independent reviewers. Studies comparing serious games to standard therapy were included. DATA EXTRACTION: Methodology and results of the studies were critically appraised in conformity with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA SYNTHESIS: Twelve articles were included, all of which tested "off-the-shelf" games. No studies on "wearable-controlled" games or games specifically developed for rehabilitation could be included. Medical conditions included postoperative rehabilitation and acute traumatic injuries. All studies were of low to moderate quality. Only 2 studies found beneficial effects of serious games compared to conventional therapy. One of 3 studies reporting pain scores found beneficial effects of serious games compared to physiotherapy. One of 5 trials reporting treatment adherence found a statistically significant advantage in the game group compared to conventional physiotherapy. Because of heterogeneity in study design and outcome measures, pooling of data was not possible. CONCLUSIONS: Serious games seem a safe alternative or addition to conventional physiotherapy after traumatic bone and soft tissue injuries. Future research should determine their validity and effectiveness in rehabilitation therapy, next to their cost-effectiveness and effect on treatment adherence.

Game-based training improves the surgeon's situational awareness in the operation room: a randomized controlled trial.

BACKGROUND: Equipment-related malfunctions directly relate to one-fourth of the adverse events in the surgical theater. A serious game trains residents to recognize and respond to equipment problems in minimally invasive surgery (MIS). These include disturbed vision, gas transport, electrocautery, and pathophysiological disturbances. This randomized controlled trial explores whether game-based training improves surgical residents' response to equipment-related problems during surgery. METHODS: Thirty-one surgical residents with no previous experience in MIS took part in a standardized basic laparoscopy training course. Fifteen residents were randomly assigned to the game-enhanced curriculum (intervention) and sixteen were assigned to the regular curriculum (control). Participants performed a MIS task in a live anesthetized pig model, during which three standardized equipment malfunction scenarios occurred. Observers recorded the problems recognized and solved, time, and participants' technical performance. RESULTS: Twenty-four participants completed the post-test (n = 12 per group). The intervention group solved more problems than the control group (59 vs. 33%, p = 0.029). The intervention group also recognized a larger proportion of problems, although this parameter was non-significant (67 vs. 42%, p = 0.14). Random effects modeling showed a significant improved game performance per participant over time. CONCLUSIONS: Surgical residents, who play for only 1 h on a custom-made serious game, respond significantly better to equipment-related problems during surgery than residents trained by a standard training curriculum. These results imply that entertaining serious games can indeed be considered for use in official training for surgeons and other medical specialists.

Mapping the Demand for Serious Games in Postgraduate Medical Education Using the Entrustable Professional Activities Framework.

OBJECTIVE: Serious games are potentially powerful tools for residency training and increasingly attract attention from medical educators. At present, serious games have little evidence-based relations with competency-based medical education, which may impede their incorporation into residency training programs. The aim of this study was to identify highly valued entrustable professional activities (EPAs) to support designers in the development of new, serious games built on a valid needs-assessment. MATERIALS AND METHODS: All 149 licensed medical specialists from seven specialties in one academic hospital participated in seven different Delphi expert panels. They filled out a two-round Delphi survey, aimed at identifying the most valuable EPAs in their respective curricula. Specialists were asked to name the most highly valued EPA in their area in the first Delphi round. In the second round, the generated responses were presented and ranked according to priority by the medical specialists. RESULTS: Sixty-two EPAs were identified as valuable training subjects throughout five specialties. Eleven EPAs--"management of trauma patient," "chest tube placement," "laparoscopic cholecystectomy," "assessment of vital signs," "airway management," "induction of general anesthesia," "assessment of suicidal patient," "psychiatric assessment," "gastroscopy," "colonoscopy," and "resuscitation of emergency patients"--were consistently given a high score. CONCLUSIONS: The future medical specialist is an active learner, comfortable with digital techniques and learning strategies such as serious gaming. In order to maximize the impact and acceptance of new serious games, it is vital to select the most relevant training subjects. Although some serious games have already targeted top-priority EPAs, plenty of opportunities remain.

[Situational awareness: you won't see it unless you understand it]. / Situational awareness: je gaat het pas zien als je het doorhebt.

In dynamic, high-risk environments such as the modern operating theatre, healthcare providers are required to identify a multitude of signals correctly and in time. Errors resulting from failure to identify or interpret signals correctly lead to calamities. Medical training curricula focus largely on teaching technical skills and knowledge, not on the cognitive skills needed to interact appropriately with fast-changing, complex environments in practice. The term 'situational awareness' describes the dynamic process of receiving, interpreting and processing information in such dynamic environments. Improving situational awareness in high-risk environments should be part of medical curricula. In addition, the flood of information in high-risk environments should be presented more clearly and effectively. It is important that physicians become more involved in this regard.

Appraisal of face and content validity of a serious game improving situational awareness in surgical training.

BACKGROUND: Equipment-related malfunctions during minimally invasive surgery (MIS) are common and threaten patient safety. As they occur in the periphery of the surgeon's vision, the surgical team requires a high level of situational awareness in order to intercept these errors timely. A serious game has been developed to train surgical residents to deal with equipment-related errors. This study investigates to what extent surgical educators and trainees would accept a serious game as a training method. MATERIALS AND METHODS: A cross-sectional survey was conducted among 45 surgeons, surgical residents, and medical students who played the serious game at a scientific convention. The questionnaire contained statements on perceived realism, usefulness, teaching capability, user experience and application toward surgical training. RESULTS were analyzed according to participants' MIS experience ("expert," "intermediate," and "novice"). RESULTS: The majority found that important medical constructs are represented realistically (64.4%-88.9%) and indicated the game to be particularly useful for training operating room nurses and surgical residents (75%-86%). Both educators and trainees found the game to be useful for surgical training (53%). Serious gaming was viewed as positive (78%) and challenging (60%), and 66% would play the game in their leisure time. Licensed surgeons perceived the game more frequently as boring than the intermediate-level and trainee groups (23.5% versus 6.7% and 8.3%; P=.045). CONCLUSIONS: This is the first study to show acceptance of a serious game as a training format in surgical training by educators and trainees. Future research should investigate whether the serious game indeed improves problem-solving and situational awareness in the operating room.

A serious game can be a valid method to train clinical decision-making in surgery.

BACKGROUND: A serious game was developed to train surgical residents in clinical decision-making regarding biliary tract disease. Serious or applied gaming is a novel educational approach to postgraduate training, combining training and assessment of clinical decision-making in a fun and challenging way. Although interest for serious games in medicine is rising, evidence on its validity is lacking. This study investigates face, content, and construct validity of this serious game. METHODS: Experts structurally validated the game's medical content. Subsequently, 41 participants played the game. Decision scores and decision speed were compared among surgeons, surgical residents, interns, and medical students, determining the game's discriminatory ability between different levels of expertise. After playing, participants completed a questionnaire on the game's perceived realism and teaching ability. RESULTS: Surgeons solved more cases correctly (mean 77 %) than surgical residents (67 %), interns (60 %), master-degree students (50 %), and bachelor-degree students (39 % (p < 0.01). Trainees performed significantly better in their second play session than in the first (median 72 vs. 48 %, p = 0.00). Questionnaire results showed that educators and surgical trainees found the game both realistic and useful for surgical training. The majority perceived the game as fun (91.2 %), challenging (85.3 %), and would recommend the game to educate their colleagues (81.8 %). CONCLUSIONS: This serious game showed clear discriminatory ability between different levels of expertise in biliary tract disease management and clear teaching capability. It was perceived as appealing and realistic. Serious gaming has the potential to increase adherence to training programs in surgical residency training and medical school.

Prospective cohort study on surgeons' response to equipment failure in the laparoscopic environment.

BACKGROUND: Equipment malfunction accounts for approximately one-fourth of surgical errors in the operating room. A serious game was developed to train surgeons in recognizing and responding to equipment failure in minimally invasive surgery (MIS) adequately. This study determined the baseline performance of surgeons, surgical residents, surgical novices, and MIS equipment technicians in solving MIS equipment failure. METHODS: The serious game included 37 problem scenarios on the subjects lighting and imaging, insufflation and gas transport, electrosurgery, and pathophysiological disturbances. The scenarios were validated by laparoscopic surgeons and MIS equipment specialists. Forty-nine licensed surgeons, surgical residents, medical students, and MIS equipment specialists played four sessions on the serious game at a surgical convention. Scores on different outcome parameters were compared between groups of a different MIS experience. RESULTS: Laparoscopic equipment specialists solved significantly more MIS equipment-related problems than surgical novices, intermediates, and experts (68.9 vs. 51.0 %, 51.4, and 45.0 %, respectively, p = 0.01). Laparoscopic equipment specialists required significantly fewer steps to solve a problem accurately (median of 1.0 vs. 2.0 for the other groups). Most notably, experienced surgeons were unable to outperform novice and intermediate groups. Experienced surgeons took less time to solve the problems, but made more mistakes in doing so. CONCLUSIONS: Experienced surgeons did not outperform inexperienced surgeons in dealing with laparoscopic equipment failure. These results are worrying and need to be addressed by the surgical community.

A multicenter prospective cohort study on camera navigation training for key user groups in minimally invasive surgery.

BACKGROUND: Untrained laparoscopic camera assistants in minimally invasive surgery (MIS) may cause suboptimal view of the operating field, thereby increasing risk for errors. Camera navigation is often performed by the least experienced member of the operating team, such as inexperienced surgical residents, operating room nurses, and medical students. The operating room nurses and medical students are currently not included as key user groups in structured laparoscopic training programs. A new virtual reality laparoscopic camera navigation (LCN) module was specifically developed for these key user groups. METHODS: This multicenter prospective cohort study assesses face validity and construct validity of the LCN module on the Simendo virtual reality simulator. Face validity was assessed through a questionnaire on resemblance to reality and perceived usability of the instrument among experts and trainees. Construct validity was assessed by comparing scores of groups with different levels of experience on outcome parameters of speed and movement proficiency. RESULTS: The results obtained show uniform and positive evaluation of the LCN module among expert users and trainees, signifying face validity. Experts and intermediate experience groups performed significantly better in task time and camera stability during three repetitions, compared to the less experienced user groups (P < .007). Comparison of learning curves showed significant improvement of proficiency in time and camera stability for all groups during three repetitions (P < .007). CONCLUSION: The results of this study show face validity and construct validity of the LCN module. The module is suitable for use in training curricula for operating room nurses and novice surgical trainees, aimed at improving team performance in minimally invasive surgery.

How to systematically assess serious games applied to health care.

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.

Designing a proficiency-based, content validated virtual reality curriculum for laparoscopic colorectal surgery: a Delphi approach.

BACKGROUND: Although task training on virtual reality (VR) simulators has been shown to transfer to the operating room, to date no VR curricula have been described for advanced laparoscopic procedures. The purpose of this study was to develop a proficiency-based VR technical skills curriculum for laparoscopic colorectal surgery. METHODS: The Delphi method was used to determine expert consensus on which VR tasks (on the LapSim simulator) are relevant to teaching laparoscopic colorectal surgery. To accomplish this task, 19 international experts rated all the LapSim tasks on a Likert scale (1-5) with respect to the degree to which they thought that a particular task should be included in a final technical skills curriculum. Results of the survey were sent back to participants until consensus (Cronbach's α >0.8) was reached. A cross-sectional design was utilized to define the benchmark scores for the identified tasks. Nine expert surgeons completed all identified tasks on the "easy," "medium," and "hard" settings of the simulator. RESULTS: In the first round of the survey, Cronbach's α was 0.715; after the second round, consensus was reached at 0.865. Consensus was reached for 7 basic tasks and 1 advanced suturing task. Median expert time and economy of movement scores were defined as benchmarks for all curricular tasks. CONCLUSION: This study used Delphi consensus methodology to create a curriculum for an advanced laparoscopic procedure that is reflective of current clinical practice on an international level and conforms to current educational standards of proficiency-based training.

Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions.

Inadequate surgical margins represent a high risk for adverse clinical outcome in breast-conserving therapy (BCT) for early-stage breast cancer. The majority of studies report positive resection margins in 20% to 40% of the patients who underwent BCT. This may result in an increased local recurrence (LR) rate or additional surgery and, consequently, adverse affects on cosmesis, psychological distress, and health costs. In the literature, various risk factors are reported to be associated with positive margin status after lumpectomy, which may allow the surgeon to distinguish those patients with a higher a priori risk for re-excision. However, most risk factors are related to tumor biology and patient characteristics, which cannot be modified as such. Therefore, efforts to reduce the number of positive margins should focus on optimizing the surgical procedure itself, because the surgeon lacks real-time intraoperative information on the presence of positive resection margins during breast-conserving surgery. This review presents the status of pre- and intraoperative modalities currently used in BCT. Furthermore, innovative intraoperative approaches, such as positron emission tomography, radioguided occult lesion localization, and near-infrared fluorescence optical imaging, are addressed, which have to prove their potential value in improving surgical outcome and reducing the need for re-excision in BCT.