Sandra Bucci, Cara Richardson, & Stephanie Allan (iCHARTS)

Sandra Bucci, Cara Richardson, & Stephanie Allan (iCHARTS)

A recent review by Torous and colleagues (2021) highlighted that detailed adverse events reporting is rare within the area of digital mental health, and as such, it is currently difficult to draw inferences about the safety of digital interventions. Evidence suggests that people with psychosis are willing and able to use or test digital health technologies (DHTs) to support their mental healthcare and recovery. DHTs present the unique opportunity for increased adverse events reporting and assessment of user experience due to the flexibility and adaptability of these technologies. For example, an app could have an in-built adverse event reporting function to allow users to self-report in real-time adverse events they might experience while taking part in a DHT research study. By providing participants with a range of options to report adverse events, we can record and report potential negative effects of DHTs and ensure these technologies are as safe as possible.

There is currently no consistent approach for reporting adverse events associated with digital health platforms for schizophrenia (DHPS). Convened by Professor Bucci and supported by the Schizophrenia International Research Society Research Harmonisation Award, our network is called the International Collaboration for Harmonising Adverse Events Reporting in Technology for Schizophrenia (iCHARTS). Our aim is to examine the full range of adverse events recorded and reported in DHPS trials, with a view to improving and standardising, where possible, adverse events and training procedures.

Over the past 12 months, we have successfully brought together 10 senior researchers, 14 Early Career Researchers, and three experts by experience across eight countries. During our proposed 2-year programme of work, we aim to produce a comprehensive adverse events reporting procedure, tool, and training resource to facilitate systematic reporting of adverse events in future DHPS studies. Our RHA draws on existing datasets, and members’ international expertise, to catalogue adverse events within DHPS internationally. This shared empirical data, along with an analysis of collated standard operating procedures (SOPs), will provide the basis for a harmonised reporting framework and procedure for reporting adverse events in DHPS.

The format of our iCHARTS Network has comprised wider network meetings as well as smaller Writing Group meetings (led by early career researcher members of our Network), to progress our planned programme of work. We recognise that any outputs from this Network are limited by the countries of members involved in the Network, but we look forward to producing an open-source document that can be updated and made globally relevant in due course. We also hope that the outputs from Writing Groups are “live” documents, open to feedback and additional content from experts, including experts by experience, around the world, to ensure the outputs from this Network reflect the most up-to-date global evidence.

A year into our SIRS RHA, we have collated how adverse event definitions and procedures differ across countries. We have analysed adverse events data from a wide range of DHPS studies to produce a comprehensive list of adverse events reported in 33 (so far) DHPS trials. We have also analysed over 36 Standard Operating Procedures used in DHPS trials and utilised our international collaboration Network to understand and harmonise these procedures.

We have been struck by how open many psychosis researchers have been for sharing data about adverse events that they have collected while trialling a whole range of digital interventions. We are deeply grateful for everyone’s efforts and especially Aansha (a research assistant who is assisting with the project) for making sure that they are fully anonymised. We are still welcoming datasets and hope more will come soon. Our writing group features psychiatrists, clinical psychologists, and service user researchers from across the world and we are conducting an inductive content analysis that includes all that diverse expertise. So far, we are noticing that adverse events reports vary in the amount of detail reported.

Collating the Standard Operating Procedures has brought to light how adverse events reporting differs across trials, study designs (particularly whether the study is investigating a medical device), and countries. Whilst anecdotally researchers clearly train research workers to record and report adverse events, these training procedures do not seem to be documented consistently in trials – one of our aims is to produce a training procedure that researchers can use to train research workers in sensitively asking service users about harm, and methods to record and report adverse events in the context of DHPS trials. This is where the group benefits from international collaboration to draw on the expertise of members, to understand more about these procedures.

As we move into Year 2 of the RHA Network, we will continue to harmonise our reporting procedures and would like to draw on the SIRS member community for input in how we can further develop adverse events procedures. The Network recognises and value the perspectives of our expert by experience members. Encouragement of mentor/mentee meetings between senior and early career researchers has also highlighted the value of mentorship and provided the opportunity to further collaborations between digital mental health researchers both nationally and internationally.

The Research Harmonisation Award allows sharing and/or comparing data across countries to accelerate schizophrenia research internationally. You can find out more by clicking here.

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