PMID- 33353566 OWN - NLM STAT- MEDLINE DCOM- 20210104 LR - 20231110 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 21 IP - 1 DP - 2020 Dec 22 TI - Advantages of visualisations to evaluate and communicate adverse event information in randomised controlled trials. PG - 1028 LID - 10.1186/s13063-020-04903-0 [doi] LID - 1028 AB - BACKGROUND: Randomised controlled trials (RCTs) provide valuable information and inform the development of harm profiles of new treatments. Harms are typically assessed through the collection of adverse events (AEs). Despite AEs being routine outcomes collected in trials, analysis and reporting of AEs in journal articles are continually shown to be suboptimal. One key challenge is the large volume of AEs, which can make evaluation and communication problematic. Prominent practice is to report frequency tables of AEs by arm. Visual displays offer an effective solution to assess and communicate complex information; however, they are rarely used and there is a lack of practical guidance on what and how to visually display complex AE data. METHODS: In this article, we demonstrate the use of two plots identified to be beneficial for wide use in RCTs, since both can display multiple AEs and are suitable to display point estimates for binary, count, or time-to-event AE data: the volcano and dot plots. We compare and contrast the use of data visualisations against traditional frequency table reporting, using published AE information in two placebo-controlled trials, of remdesivir for COVID-19 and GDNF for Parkinson disease. We introduce statistical programmes for implementation in Stata. RESULTS/CASE STUDY: Visualisations of AEs in the COVID-19 trial communicated a risk profile for remdesivir which differed from the main message in the published authors' conclusion. In the Parkinson's disease trial of GDNF, the visualisation provided immediate communication of harm signals, which had otherwise been contained within lengthy descriptive text and tables. Asymmetry in the volcano plot helped flag extreme events that were less obvious from review of the frequency table and dot plot. The dot plot allowed a more comprehensive representation by means of a more detailed summary. CONCLUSIONS: Visualisations can better support investigators to assimilate large volumes of data and enable improved informal between-arm comparisons compared to tables. We endorse increased uptake for use in trial publications. Care in construction of visual displays needs to be taken as there can be potential to overemphasise treatment effects in some circumstances. FAU - Cornelius, Victoria AU - Cornelius V AUID- ORCID: 0000-0002-0080-1065 AD - Imperial Clinical Trials Unit, Imperial College London, 1st Floor Stadium House, 68 Wood Lane, London, W12 7RH, UK. v.cornelius@imperial.ac.uk. FAU - Cro, Suzie AU - Cro S AD - Imperial Clinical Trials Unit, Imperial College London, 1st Floor Stadium House, 68 Wood Lane, London, W12 7RH, UK. FAU - Phillips, Rachel AU - Phillips R AD - Imperial Clinical Trials Unit, Imperial College London, 1st Floor Stadium House, 68 Wood Lane, London, W12 7RH, UK. LA - eng GR - DRF-2017-10-131/DH_/Department of Health/United Kingdom PT - Journal Article DEP - 20201222 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Antiparkinson Agents) RN - 0 (Antiviral Agents) RN - 0 (Glial Cell Line-Derived Neurotrophic Factor) RN - 3QKI37EEHE (remdesivir) RN - 415SHH325A (Adenosine Monophosphate) RN - OF5P57N2ZX (Alanine) SB - IM MH - Adenosine Monophosphate/adverse effects/*analogs & derivatives MH - Alanine/adverse effects/*analogs & derivatives MH - Antiparkinson Agents/adverse effects MH - Antiviral Agents/adverse effects MH - Computer Graphics MH - Data Accuracy MH - Data Analysis MH - *Data Display MH - *Data Visualization MH - Drug Monitoring/methods MH - Drug-Related Side Effects and Adverse Reactions/*diagnosis MH - Glial Cell Line-Derived Neurotrophic Factor/*adverse effects MH - Humans MH - Parkinson Disease/*drug therapy MH - Randomized Controlled Trials as Topic MH - Research Design/*standards MH - *COVID-19 Drug Treatment PMC - PMC7754702 OTO - NOTNLM OT - Adverse events OT - Adverse reactions OT - Data analysis OT - Graphics OT - Harms OT - Randomised controlled trials OT - Reporting OT - Visualisation COIS- All authors declare that they have no competing interests. EDAT- 2020/12/24 06:00 MHDA- 2021/01/05 06:00 PMCR- 2020/12/22 CRDT- 2020/12/23 05:30 PHST- 2020/06/08 00:00 [received] PHST- 2020/11/15 00:00 [accepted] PHST- 2020/12/23 05:30 [entrez] PHST- 2020/12/24 06:00 [pubmed] PHST- 2021/01/05 06:00 [medline] PHST- 2020/12/22 00:00 [pmc-release] AID - 10.1186/s13063-020-04903-0 [pii] AID - 4903 [pii] AID - 10.1186/s13063-020-04903-0 [doi] PST - epublish SO - Trials. 2020 Dec 22;21(1):1028. doi: 10.1186/s13063-020-04903-0.