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. 2018 Mar;23(3):337-345.
doi: 10.1634/theoncologist.2017-0196. Epub 2017 Nov 13.

Quality of Randomized Controlled Trials Reporting in the Treatment of Adult Patients with High-Grade Gliomas

Magalie P Tardy  1 , Jocelyn Gal  2 , Emmanuel Chamorey  2 , Fabien Almairac  3 , Fanny Vandenbos  4 , Pierre-Yves Bondiau  5 , Esma Saada-Bouzid  6
Affiliations

Quality of Randomized Controlled Trials Reporting in the Treatment of Adult Patients with High-Grade Gliomas

Magalie P Tardy et al. Oncologist. 2018 Mar.

Abstract

Background: The randomized controlled trial (RCT) is the gold standard to objectively assess the effect of treatments. To help improve the quality of RCTs, experts established a list of recommendations, the CONsolidated Standards of Reporting Trials (CONSORT) Statement. In this study, we evaluated the implementation of the CONSORT Statement in the field of high-grade gliomas in adult patients and looked for criteria associated with higher quality of RCTs.

Materials and methods: We searched all high-grade gliomas RCTs published in PubMed between January 1990 and December 2016. The quality of these RCTs was assessed by completing a modified CONSORT Score (CS).

Results: Ninety-six published RCTs were identified. The median CS was 19.5 on a scale of 0-33. Items were not equally reported. Items regarding the method of randomization or the blinding were reported in less than 25% of RCTs. However, the CS has constantly improved over the years. Before the implementation of the CONSORT Statement in 1996, the median CS was 13, whereas it was 17 for the period 1996-2004 and 22 after 2005. A higher CS was observed when RCTs were published in a journal with an impact factor above 10 (p < .001) or after 2010 (p = .001), when the primary outcome was clearly defined (p < .001) and for RCTs that enrolled more than 200 patients (p = .004).

Conclusion: Although there has been a steady improvement in the CS over the years in the field of high-grade gliomas, a major effort must be made in the reporting methods for randomization and blinding.

Implications for practice: This study showed that the quality of reporting of randomized control trials (RCTs) concerning the treatment of high-grade gliomas is poor. Factors associated with a better quality of reports were identified and should be incorporated into the design of future RCTs. When clinicians read the results of RCTs, they should be aware of the possible inadequate reporting from these trials and take it into account for the management of their patients. This study identifies how RCTs can be improved in their reporting but also in their design, in order to advance care for patients with high-grade gliomas in the future.

Keywords: CONSORT statement; Glioblastoma; Glioma; Quality report; Randomized controlled trial.

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Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1.
Figure 1.
Flow diagram of the randomized controlled trials selection method.
See this image and copyright information in PMC

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