Adherence to CONSORT Guidelines and Reporting of the Determinants of External Validity in Clinical Oncology Randomized Controlled Trials: A Review of Trials Published in Four Major Journals between 2013 and 2015 Article Swipe
Sophie Audet
,
Catherine Doyle
,
Christopher Lemieux
,
Marc-Antoine Tardif
,
Andréa Gauvreau
,
David Simonyan
,
Hermann Nabi
,
Julie Lemieux
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.3390/curroncol30020160
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.3390/curroncol30020160
Our primary objective was to determine the proportion of trials that report the number of patients assessed for eligibility before randomization. We performed the systematic retrieval and analysis of all phase II, III, and IV RCTs published between 2013 and 2015 in four high-impact-factor journals in the field of clinical oncology. Among 456 RCTs reviewed, 236 trials (51.8%) reported the number of patients assessed for eligibility. Among the 236 trials that reported the entire enrollment process, the reasons for patient exclusion could be found in 184 trials (78%). A flow diagram was presented in 452 trials (99.1%), and 98 trials (21.5%) included a discussion on generalizability. Reporting the parameters of external validity in medical oncology RCTs is challenging. Improving adherence to the 2010 CONSORT guidelines concerning the enrollment process could help clinicians and health policymakers establish to whom trial results apply.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.3390/curroncol30020160
- https://www.mdpi.com/1718-7729/30/2/160/pdf?version=1675839047
- OA Status
- gold
- Cited By
- 4
- References
- 19
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4319594413
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W4319594413Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.3390/curroncol30020160Digital Object Identifier
- Title
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Adherence to CONSORT Guidelines and Reporting of the Determinants of External Validity in Clinical Oncology Randomized Controlled Trials: A Review of Trials Published in Four Major Journals between 2013 and 2015Work title
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reviewOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
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2023-02-08Full publication date if available
- Authors
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Sophie Audet, Catherine Doyle, Christopher Lemieux, Marc-Antoine Tardif, Andréa Gauvreau, David Simonyan, Hermann Nabi, Julie LemieuxList of authors in order
- Landing page
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https://doi.org/10.3390/curroncol30020160Publisher landing page
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https://www.mdpi.com/1718-7729/30/2/160/pdf?version=1675839047Direct link to full text PDF
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://www.mdpi.com/1718-7729/30/2/160/pdf?version=1675839047Direct OA link when available
- Concepts
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Medicine, Generalizability theory, Clinical trial, External validity, Consolidated Standards of Reporting Trials, Randomization, Randomized controlled trial, Alternative medicine, Family medicine, Internal medicine, Pathology, Social psychology, Statistics, Mathematics, PsychologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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4Total citation count in OpenAlex
- Citations by year (recent)
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2025: 2, 2024: 1, 2023: 1Per-year citation counts (last 5 years)
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19Number of works referenced by this work
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-
10Other works algorithmically related by OpenAlex
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