Evidence map›Paper›PMID 38581410›Full record

SynthesisSchizophrenia bulletin2024

Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports.

Stephanie Allan, Thomas Ward, Emily Eisner, Imogen H Bell, Matteo Cella, Imran B Chaudhry, John Torous, Tayyeba Kiran, Thomas Kabir, Aansha Priyam and 7 more

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Schizophrenia bulletin, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Stephanie AllanSchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Thomas WardSchool of Mental Health and Psychological Sciences, Department of Psychology Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Emily EisnerDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, UK.
Imogen H BellOrygen, Parkville, VIC, Australia.ORCID 0000-0001-7567-0517
Matteo CellaSchool of Mental Health and Psychological Sciences, Department of Psychology Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.ORCID 0000-0002-5701-0336
Imran B ChaudhryDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, UK.
John TorousDepartment of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-5362-7937
Tayyeba KiranCentre for Youth Mental Health, University of Melbourne, Parkville, VIC, Australia.
Thomas KabirDepartment of Psychiatry, University of Oxford, Oxford, UK.
Aansha PriyamDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, UK.
Cara RichardsonDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, UK.
Ulrich ReininghausSchool of Mental Health and Psychological Sciences, Department of Psychology Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Anita SchickDepartment of Psychiatry, University of Oxford, Oxford, UK.ORCID 0000-0002-2043-0353
Matthias SchwannauerDepartment of Clinical and Health Psychology, School of Health in Social Science, University of Edinburgh, Edinburgh, UK.
Suzy SyrettSchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Xiaolong ZhangDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, UK.
Sandra BucciDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, UK.

Funding

Department of Health and Social CareManchester Biomedical Research Centre NIHR203308NIHR Research ProfessorshipSchizophrenia International Research SocietyUniversity of Manchester
6 · The paper itself

Abstract

backgroundDigital health interventions (DHIs) have significant potential to upscale treatment access to people experiencing psychosis but raise questions around patient safety. Adverse event (AE) monitoring is used to identify, record, and manage safety issues in clinical trials, but little is known about the specific content and context contained within extant AE reports. This study aimed to assess current AE reporting in DHIs. STUDY

designA systematic literature search was conducted by the iCharts network (representing academic, clinical, and experts by experience) to identify trials of DHIs in psychosis. Authors were invited to share AE reports recorded in their trials. A content analysis was conducted on the shared reports. STUDY

resultsWe identified 593 AE reports from 18 DHI evaluations, yielding 19 codes. Only 29 AEs (4.9% of total) were preidentified by those who shared AEs as being related to the intervention or trial procedures. While overall results support the safety of DHIs, DHIs were linked to mood problems and psychosis exacerbation in a few cases. Additionally, 27% of studies did not report information on relatedness for all or at least some AEs; 9.6% of AE reports were coded as unclear because it could not be determined what had happened to participants.

conclusionsThe results support the safety of DHIs, but AEs must be routinely monitored and evaluated according to best practice. Individual-level analyses of AEs have merit to understand safety in this emerging field. Recommendations for best practice reporting in future studies are provided.

Indexed as

Psychotic DisordersHumansTelemedicineadverse effectsdigital healthpsychosissafetyschizophrenia

Identifiers

PMID38581410
PMCPMC11548921

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.