Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline
BackgroundExtended reality (XR), encompassing technologies such as virtual reality, augmented reality, and mixed reality, has rapidly gained prominence in health care. However, existing XR research often lacks rigor, proper controls, and standardization. Objective...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2024-11-01
|
| Series: | Journal of Medical Internet Research |
| Online Access: | https://www.jmir.org/2024/1/e56790 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846149344752828416 |
|---|---|
| author | Johan H Vlake Denzel LQ Drop Jasper Van Bommel Giuseppe Riva Brenda K Wiederhold Pietro Cipresso Albert S Rizzo Barbara O Rothbaum Cristina Botella Lotty Hooft Oscar J Bienvenu Christian Jung Bart Geerts Evert-Jan Wils Diederik Gommers Michel E van Genderen |
| author_facet | Johan H Vlake Denzel LQ Drop Jasper Van Bommel Giuseppe Riva Brenda K Wiederhold Pietro Cipresso Albert S Rizzo Barbara O Rothbaum Cristina Botella Lotty Hooft Oscar J Bienvenu Christian Jung Bart Geerts Evert-Jan Wils Diederik Gommers Michel E van Genderen |
| author_sort | Johan H Vlake |
| collection | DOAJ |
| description |
BackgroundExtended reality (XR), encompassing technologies such as virtual reality, augmented reality, and mixed reality, has rapidly gained prominence in health care. However, existing XR research often lacks rigor, proper controls, and standardization.
ObjectiveTo address this and to enhance the transparency and quality of reporting in early-phase clinical evaluations of XR applications, we present the “Reporting for the early-phase clinical evaluation of applications using extended reality” (RATE-XR) guideline.
MethodsWe conducted a 2-round modified Delphi process involving experts from diverse stakeholder categories, and the RATE-XR is therefore the result of a consensus-based, multistakeholder effort.
ResultsThe guideline comprises 17 XR-specific (composed of 18 subitems) and 14 generic reporting items, each with a complementary Explanation & Elaboration section.
ConclusionsThe items encompass critical aspects of XR research, from clinical utility and safety to human factors and ethics. By offering a comprehensive checklist for reporting, the RATE-XR guideline facilitates robust assessment and replication of early-stage clinical XR studies. It underscores the need for transparency, patient-centeredness, and balanced evaluation of the applications of XR in health care. By providing an actionable checklist of minimal reporting items, this guideline will facilitate the responsible development and integration of XR technologies into health care and related fields. |
| format | Article |
| id | doaj-art-bc9010d6f4b942aeabc0bf6788d9c849 |
| institution | Kabale University |
| issn | 1438-8871 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | Journal of Medical Internet Research |
| spelling | doaj-art-bc9010d6f4b942aeabc0bf6788d9c8492024-11-29T19:00:33ZengJMIR PublicationsJournal of Medical Internet Research1438-88712024-11-0126e5679010.2196/56790Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study GuidelineJohan H Vlakehttps://orcid.org/0000-0002-0532-0252Denzel LQ Drophttps://orcid.org/0009-0002-8825-180XJasper Van Bommelhttps://orcid.org/0000-0001-8408-0500Giuseppe Rivahttps://orcid.org/0000-0003-3657-106XBrenda K Wiederholdhttps://orcid.org/0000-0002-3320-0303Pietro Cipressohttps://orcid.org/0000-0002-0662-7678Albert S Rizzohttps://orcid.org/0000-0003-2647-7731Barbara O Rothbaumhttps://orcid.org/0000-0002-8793-7124Cristina Botellahttps://orcid.org/0000-0001-8783-6959Lotty Hoofthttps://orcid.org/0000-0002-7950-2980Oscar J Bienvenuhttps://orcid.org/0000-0002-8466-102XChristian Junghttps://orcid.org/0000-0001-8325-250XBart Geertshttps://orcid.org/0000-0002-0210-7202Evert-Jan Wilshttps://orcid.org/0000-0002-2868-0920Diederik Gommershttps://orcid.org/0000-0001-6808-7702Michel E van Genderenhttps://orcid.org/0000-0001-5668-3435 BackgroundExtended reality (XR), encompassing technologies such as virtual reality, augmented reality, and mixed reality, has rapidly gained prominence in health care. However, existing XR research often lacks rigor, proper controls, and standardization. ObjectiveTo address this and to enhance the transparency and quality of reporting in early-phase clinical evaluations of XR applications, we present the “Reporting for the early-phase clinical evaluation of applications using extended reality” (RATE-XR) guideline. MethodsWe conducted a 2-round modified Delphi process involving experts from diverse stakeholder categories, and the RATE-XR is therefore the result of a consensus-based, multistakeholder effort. ResultsThe guideline comprises 17 XR-specific (composed of 18 subitems) and 14 generic reporting items, each with a complementary Explanation & Elaboration section. ConclusionsThe items encompass critical aspects of XR research, from clinical utility and safety to human factors and ethics. By offering a comprehensive checklist for reporting, the RATE-XR guideline facilitates robust assessment and replication of early-stage clinical XR studies. It underscores the need for transparency, patient-centeredness, and balanced evaluation of the applications of XR in health care. By providing an actionable checklist of minimal reporting items, this guideline will facilitate the responsible development and integration of XR technologies into health care and related fields.https://www.jmir.org/2024/1/e56790 |
| spellingShingle | Johan H Vlake Denzel LQ Drop Jasper Van Bommel Giuseppe Riva Brenda K Wiederhold Pietro Cipresso Albert S Rizzo Barbara O Rothbaum Cristina Botella Lotty Hooft Oscar J Bienvenu Christian Jung Bart Geerts Evert-Jan Wils Diederik Gommers Michel E van Genderen Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline Journal of Medical Internet Research |
| title | Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline |
| title_full | Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline |
| title_fullStr | Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline |
| title_full_unstemmed | Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline |
| title_short | Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline |
| title_sort | reporting guidelines for the early phase clinical evaluation of applications using extended reality rate xr qualitative study guideline |
| url | https://www.jmir.org/2024/1/e56790 |
| work_keys_str_mv | AT johanhvlake reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT denzellqdrop reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT jaspervanbommel reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT giusepperiva reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT brendakwiederhold reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT pietrocipresso reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT albertsrizzo reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT barbaraorothbaum reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT cristinabotella reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT lottyhooft reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT oscarjbienvenu reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT christianjung reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT bartgeerts reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT evertjanwils reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT diederikgommers reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline AT michelevangenderen reportingguidelinesfortheearlyphaseclinicalevaluationofapplicationsusingextendedrealityratexrqualitativestudyguideline |