Core Outcome Measures in Effectiveness Trials

Patient-oriented outcome in brain tumor patients within and across clinical trials

General Information

The current lack of a comprehensive clinical evaluation strategy in brain tumor clinical trials hampers comparative effectiveness. Standardized outcome measures would improve the ability to compare and, where appropriate, combine findings across studies and meta-analyses. To start this challenging process of investigation, the highest rating is accorded to systematic reviews that synthesize large amounts of evidence from relevant and available sources. To date, no such review has addressed outcome measures in brain tumor patients. The present study will take an evidence-based approach to analyzing patient-oriented outcome sets gleaned from clinical trials published since 1990.

Andrea Talacchi - professor and neurosurgeon - University of Verona - P.I.

Efficace Fabio – Head health Outcomes Research Unit, GIMEMA, Rome

Taphoorn Martin - professor and neuro-oncologist -VU University Medical Center - Amsterdam

Valentini Vincenzo - professor and radiation oncologist - Università Cattolica del Sacro Cuore - Rome

Further Study Information

Current Stage:
January 2014 - January 2020
Funding source(s):
To be founded

Health Area

Disease Category

Disease Name
Brain Tumor

Target Population

Age Range
18 - 100


Nature / type of Intervention


Literature review
Systematic review

Phase II and III randomized controlled trials (RCT) in patients with malignant brain tumor (glioma and brain metastasis) published to date will be reviewed and evaluated for proof of comparative effectiveness of any type of intervention for tumor control, limited to the application of patient-oriented instruments (clinical evaluation, testing, questionnaires, tools, etc.) for assessing brain functions and patient functioning. Tracing the development of single end points over time will yield reliable information about improvements in consistency and advances in instrument innovation. In addition, describing the outcome set (overall end points reported in each study) and stratification according to the international standards will align clinical evaluation with methods used for the assessment of other diseases. Outcome reporting will be compared within the studies and assessed according to Cochrane criteria.

Stakeholders Involved

Clinical experts

Study Type

Systematic review of outcomes measured in trials

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