Non-intervention evaluation of digital technologies

  • Research type

    Research Study

  • Full title

    Non-intervention evaluation of digital technologies to improve outcome or experience for children and young people attending hospital

  • IRAS ID

    235646

  • Contact name

    Neil J Sebire

  • Contact email

    neil.sebire@gosh.nhs.uk

  • Sponsor organisation

    Great Ormond Street Hospital for Children Foundation Trust

  • Duration of Study in the UK

    9 years, 8 months, 1 days

  • Research summary

    As part of the Great Ormond Street Hospital for Children (GOSH) digital strategy, in addition to the development of a comprehensive electronic patient record (EPR) system and dedicated research data platform, we have created a Digital Research, Innovation and Virtual Environment (DRIVE) unit. One aspect of DRIVE is to evaluate novel digital technologies such as new software (apps) and devices such as wearable sensors, tablets etc regarding their possible role in the future care of patients and families at GOSH. This REC application provides the framework in which to perform this evaluation. For this study we are only evaluating existing technologies for their feasibility and potential for future clinical application. No clinical decisions or any changes to standard clinical care will be performed, rather than in parallel with standard care and monitoring, novel digital technologies will also be used in order to compare how well these might perform compared to standard practice. No devices or sensors have any significant risk, none are in any way invasive and none count as MHRA medical devices at this stage. For specific technologies, such as a wearable sensor for example, that appear promising as a potential medical device, further specific applications would be required to perform a formal clinical study of effectiveness in clinical practice. This application covers early phase feasibility and proof of principle studies, not any type of formal clinical trial.

  • REC name

    London - Bloomsbury Research Ethics Committee

  • REC reference

    17/LO/1778

  • Date of REC Opinion

    10 Nov 2017

  • REC opinion

    Favourable Opinion