Neurosurgery (Neuro Oncology)

Abstract

Background: Deficiencies in design and reporting of randomized controlled trials (RCTs) limit their validity. The quality of recent RCTs in neuro-oncology 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. 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). The impact factor was significantly associated with higher quality (p<0.01). Multi-center trials were more likely to result in positive outcomes (p = 0.02). Conclusion: 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.