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Quality of reporting of cranial irradiation techniques in randomized controlled trials of primary brain tumors: A systematic review.

ABSTRACT: BACKGROUND:To assess the quality of reporting of cranial irradiation (CR) techniques in randomized controlled trials (RCTs) of primary brain tumors. METHODS:We searched PubMed and EMBASE for RCTs of primary brain tumors, published from January 1999 to November 2019 which included CR as one of the intervention arms. We assessed the initial RCTs report on whether they reported the prespecified ten criteria for CR technique adequately. Multivariable logistic regression was performed to determine the factors that were predictive of adequate quality of reporting. RESULTS:We found 85 eligible trial reports. There was significant variability in the quality of reporting among the included studies. Total radiotherapy (RT) dose and fractionation schedule were reported adequately in more than 90% of the included trials. The organs at risk dose constraints, treatment verification procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in less than 30% of included trials. Twenty-three trials (27%) reported seven criteria or more adequately. Multivariable analysis showed that trials conducted by cooperative groups, published RT quality assurance results and having a low risk of bias in the methodological quality have higher odds of having adequate quality in reporting of CR technique (judged as adequate reporting in seven criteria or more). CONCLUSIONS:The quality of reporting on CR techniques in the RCTs of primary brain tumors is variable and suboptimal. Guidelines should be introduced to improve clarity and ensure consistency in the quality of reporting.

SUBMITTER: Tan TH

PROVIDER: S-EPMC7644083 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Quality of reporting of cranial irradiation techniques in randomized controlled trials of primary brain tumors: A systematic review.

Tan Teng Hwee TH Chen Desiree D Soon Yu Yang YY Chee Seong Tey Jeremy J

PloS one 20201105 11

<h4>Background</h4>To assess the quality of reporting of cranial irradiation (CR) techniques in randomized controlled trials (RCTs) of primary brain tumors.<h4>Methods</h4>We searched PubMed and EMBASE for RCTs of primary brain tumors, published from January 1999 to November 2019 which included CR as one of the intervention arms. We assessed the initial RCTs report on whether they reported the prespecified ten criteria for CR technique adequately. Multivariable logistic regression was performed ...[more]

PMID: 33152747

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Project description: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.

Project description:Background:We systematically reviewed the literature for trials addressing the efficacy of prophylactic cranial irradiation (PCI) in patients with non-small-cell lung cancer (NSCLC) treated with a curative intent. Methods:Randomized controlled trials (RCT) comparing PCI to no PCI in patients with NSCLC treated with a curative intent were eligible for inclusion. We searched EMBASE, MEDLINE, PubMed, and CENTRAL between 1946 and July 2016. We also received continual search alerts from PubMed through September 2017. Search terms included "non-small-cell lung carcinoma," "cranial irradiation," and "randomized controlled trials." We conducted meta-analyses using random-effects models for relative measures of treatment effect for the incidence of brain metastasis, overall survival (OS), and disease-free survival (DFS). We used Parmar's methodology to derive hazard ratios (HR) when not explicitly stated in RCTs. We narratively synthesized data for the impact of PCI on quality of life (QoL) and neurocognitive function (NCF). We assessed the quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation methodology. Results:Out of 3,548 citations captured by the search strategy, we retained 8 papers and 1 abstract, reporting on 6 eligible trials. Patients who received PCI had a significant reduction in the risk of developing brain metastases as compared with patients who did not [relative risk (RR)?=?0.37; 95% confidence interval (CI): 0.26-0.52; moderate quality evidence]. However, there was no OS benefit (HR?=?1.08, 95% CI: 0.90-1.31; moderate quality evidence). Sensitivity analysis excluding older studies did not show substantively different findings. DFS was reported in the two most recent trials that included only stage III patients. There was significant improvement in DFS with PCI (HR?=?0.67; 95% CI: 0.46-0.98; high quality evidence). Two studies that reported on QoL reported no statistically significant differences. There was no significant difference in NCF decline in the only study that reported on this outcome, except in immediate and delayed recall, as assessed by the Hopkins Verbal Learning Test. Conclusion:There is moderate quality evidence that the use of PCI in patients with NSCLC decreases the risk of brain metastases, but does not provide an OS benefit. However, data limited to stage III patients suggests that PCI improves DFS, with no effect on QoL.

Dataset Information

Quality of reporting of cranial irradiation techniques in randomized controlled trials of primary brain tumors: A systematic review.

Publications

Quality of reporting of cranial irradiation techniques in randomized controlled trials of primary brain tumors: A systematic review.

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