Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations
Background: Outcome reporting bias (ORB) is widely reported in the medical literature, but the contribution from published graphical illustrations is unknown. The aim of this study was to investigate the occurrence of ORB in contemporary nephrology clinical trials relating to the choice of outcomes...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-08-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422000412 |
| _version_ | 1818158069119451136 |
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| author | Frank Ward Frances Shiely |
| author_facet | Frank Ward Frances Shiely |
| author_sort | Frank Ward |
| collection | DOAJ |
| description | Background: Outcome reporting bias (ORB) is widely reported in the medical literature, but the contribution from published graphical illustrations is unknown. The aim of this study was to investigate the occurrence of ORB in contemporary nephrology clinical trials relating to the choice of outcomes reported through graphical illustrations. Methods: An observational study was conducted using nephrology clinical trials searched from five high-impact medical journals from 2015 to 2020. Eligible trials reported a phase 2, 3 or 4 trial, contained at least one published outcome graphical illustration and were registered on a clinical trial registry. The primary outcome was the occurrence of ORB based on the choice of graphical illustrations in published trial manuscripts, deemed to be present if a graphical illustration displayed a secondary or unregistered outcome ahead of a trial's primary outcome, or if any unregistered trial outcome was presented as a graphical illustration. Results: In 75 eligible clinical trials, the primary outcome for ORB was present in 60% of the trials (n = 45). Occurrence of the primary outcome did not differ significantly based on trial sample size, funding model, trial phase, individual medical journal or publication year. An unregistered trial outcome was graphically illustrated in 93% (n = 42) of those clinical trials with ORB present. Conclusion: Outcome reporting bias based on the choice of graphical illustration is common, driven primarily by graphical illustration of unregistered trial outcomes. More appropriate choice of outcomes for graphical illustrations by authors, coupled with both increased enforcement of CONSORT guidelines by medical journals and specific guidelines for graphical illustrations choice, are desirable to address these findings. |
| first_indexed | 2024-12-11T15:24:13Z |
| format | Article |
| id | doaj.art-de4b7315a6be4f6ebd44d95928f9f079 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-11T15:24:13Z |
| publishDate | 2022-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-de4b7315a6be4f6ebd44d95928f9f0792022-12-22T01:00:16ZengElsevierContemporary Clinical Trials Communications2451-86542022-08-0128100924Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrationsFrank Ward0Frances Shiely1Department of Nephrology, Tallaght University Hospital, Dublin, Ireland; Corresponding author. Department of Nephrology, Tallaght University Hospital, Dublin, 24, Ireland.Health Research Board Clinical Research Facility, University College Cork, Ireland; School of Public Health, University College Cork, Cork, IrelandBackground: Outcome reporting bias (ORB) is widely reported in the medical literature, but the contribution from published graphical illustrations is unknown. The aim of this study was to investigate the occurrence of ORB in contemporary nephrology clinical trials relating to the choice of outcomes reported through graphical illustrations. Methods: An observational study was conducted using nephrology clinical trials searched from five high-impact medical journals from 2015 to 2020. Eligible trials reported a phase 2, 3 or 4 trial, contained at least one published outcome graphical illustration and were registered on a clinical trial registry. The primary outcome was the occurrence of ORB based on the choice of graphical illustrations in published trial manuscripts, deemed to be present if a graphical illustration displayed a secondary or unregistered outcome ahead of a trial's primary outcome, or if any unregistered trial outcome was presented as a graphical illustration. Results: In 75 eligible clinical trials, the primary outcome for ORB was present in 60% of the trials (n = 45). Occurrence of the primary outcome did not differ significantly based on trial sample size, funding model, trial phase, individual medical journal or publication year. An unregistered trial outcome was graphically illustrated in 93% (n = 42) of those clinical trials with ORB present. Conclusion: Outcome reporting bias based on the choice of graphical illustration is common, driven primarily by graphical illustration of unregistered trial outcomes. More appropriate choice of outcomes for graphical illustrations by authors, coupled with both increased enforcement of CONSORT guidelines by medical journals and specific guidelines for graphical illustrations choice, are desirable to address these findings.http://www.sciencedirect.com/science/article/pii/S2451865422000412Outcome reporting biasGraphical illustrationsRandomized clinical trialsClinical trial registration |
| spellingShingle | Frank Ward Frances Shiely Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations Contemporary Clinical Trials Communications Outcome reporting bias Graphical illustrations Randomized clinical trials Clinical trial registration |
| title | Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations |
| title_full | Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations |
| title_fullStr | Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations |
| title_full_unstemmed | Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations |
| title_short | Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations |
| title_sort | outcome reporting bias in nephrology randomized clinical trials examining outcomes represented by graphical illustrations |
| topic | Outcome reporting bias Graphical illustrations Randomized clinical trials Clinical trial registration |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422000412 |
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