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  • Deficiencies in the Design and Reporting Quality of RCTs in Neuro-oncology

    Final Number:

    Alireza Mansouri MD; Samuel S. Shin MD PhD; Benjamin Cooper; Douglas Kondziolka MD, MSc, FRCS(C), FACS

    Study Design:

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2015 Annual Meeting

    Introduction: Randomized-Controlled Trials (RCTs) represent one of the highest qualities of evidence in medical research. Deficiencies in design and reporting of RCTs limit their validity. The quality of RCTs in neuro-oncology from 2000 to 2010 was analyzed to assess adequacy of design and reporting.

    Methods: The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2000-2010). The CONSORT and Jadad scales were used to assess the quality of design/reporting. The standardized median times cited (median citations divided by years since publication) was used to assess impact. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman’s test was used to assess correlations. Regression analysis was used to assess associations.

    Results: Overall, 44 RCTs were identified; majority (23 studies) were chemotherapy-based. High grade gliomas (43%) and metastases (41%) were top pathologies. The majority of studies were multi-center (70%), ITT (61%), and did not collaborate with biostatisticians (70%). Half of the studies were funded by industry (50%). The median CONSORT and Jadad scores were similar in radiation and chemotherapy-based trials (34 and 35 vs 3 and 2, respectively). Deficiencies in reporting pertained to sample size calculation, blinding, and allocation concealment. The impact factor was significantly associated with higher quality (p<0.01). Type of outcome did not appear to affect publication success. Multi-center trials were more likely to result in positive outcomes (p = 0.02).

    Conclusions: Deficiencies in the quality of design and reporting of RCTs in neuro-oncology persist. Quality improvement is necessary. In parallel, alternative strategies may be required.

    Patient Care: By identifying areas of deficiency providing suggestions for improvement, it is hoped that the validity of RCTs and their interpretability can be improved. In addition, alternative design strategies for when RCTs are not feasible should be discussed.

    Learning Objectives: 1) Reporting and design quality of RCTs in neuro-oncology (non-surgical trials) is deficient 2) Certain clinical queries are not amenable to RCTs and alternative strategies may be required


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