Quality of patient-reported outcome reporting according to the CONSORT statement in randomized controlled trials with glioblastoma patients

Abstract

Background Randomized controlled trials (RCTs) represent the best evidence in oncology research. Glioblastoma is the most frequent and deadly primary brain tumor, impacting health-related quality of life. An important endpoint is patient-reported outcomes (PROs). There is no data regarding how well publications of glioblastoma’s RCTs report PROs. A specific PRO extension of the CONSORT statement was created to improve quality of reporting. The aim of this study was to evaluate the adherence to the CONSORT-PRO statement in reporting RCTs dealing with the treatment of patients with glioblastoma. PROs analysis methodology was explored and criteria associated with higher quality of reporting were investigated. Methods From PubMed/MEDLINE and the Cochrane Library databases, all phase II and III RCTs related to glioblastoma published between 1995 and 2018 were reviewed according to the CONSORT-PRO statements. An overall quality score on a 0–100 scale was defined based on these criteria and factors associated with this score were identified. Results Forty-four RCTs were identified as relevant according to predefined criteria. The median overall quality score was 26. No difference was observed regarding quality of reporting over years. CONSORT-PRO items concerning data collection and analysis were poorly reported. Thirty-four trials (77%) used longitudinal data. The most frequent statistical method for PROs analysis was the mean change from baseline (63%). Factors associated with improved overall quality score were the presence of a secondary publication dedicated to PROs results, the statement of any targeted dimensions, and when trials reported results using multiple methods. Conclusion Despite importance of measuring PROs in patients with glioblastoma, employment of the CONSORT-PRO statement is poor in RCTs.

The reporting quality of randomized controlled trials in pharmacotherapy for pituitary adenomas

“…[ 22 ] Despite our study’s finding that The CONSORT OQS remains deficient; it is encouraging that we have already seen increasing uptake of the CONSORT criteria in the neurosurgery literature as a whole. [ 18 , 23 , 24 ] We observed that reporting quality improved over time and the OQS of RCTs was significantly higher when published since 2010 ( P = .012). Tardy et al also noticed an improvement in the CONSORT Score and definition of inclusion criteria over the years, revealing an effort to define more homogeneous groups.…”

“…Well-designed and properly executed RCTs provide the most reliable evidence for the efficacy of healthcare interventions; however, trials with inadequate methods are associated with bias, especially exaggerated treatment effects. [23,25] Our study has several limitations. First, improvements in study reporting based on the flaws revealed by the current research may have a disproportionately large effect on the quality of study reporting given the limited number of studies.…”

“…Well-designed and properly executed RCTs provide the most reliable evidence for the efficacy of healthcare interventions; however, trials with inadequate methods are associated with bias, especially exaggerated treatment effects. [ 23 , 25 ]…”

Recurrent Glioblastoma: Ongoing Clinical Challenges and Future Prospects

“…Therefore, it is essential to consider quality of life, patient reported outcome, and toxicity before implementing a new treatment in clinical practice. 160 , 162 …”

Quality of patient-reported outcome reporting in trials of diabetes in pregnancy: A systematic review

“…Since the publication of this guideline in 2013, a number of systematic reviewa have evaluated the quality and completeness of PRO reporting against this standard [14][15][16][17][18]; results of such reviews have shown that up to 50% of included studies show "sub-optimal reporting".…”