Research poster presentation - session V Disease-specific studies: Cancer - patient-reported outcomes & patient preference study| Volume 15, ISSUE 4, PA227, June 01, 2012

PCN108 Review of the Content Validity of the Patient Reported Outcome Measures Used in Patients With Brain Metastases


      According to the FDA Patient-reported outcome (PRO) Guidance, evidence of input from the appropriate population during the development of a PRO measure is critical to determine whether a measure is applicable. A literature review was conducted to identify the symptoms and impacts (concepts) of brain metastases (BM) and the key PRO measures used in BM to compare their development and content validity.


      Literature searches were conducted using MEDLINE®. PRO measures were reviewed for patient input and the concepts reported in the clinical literature on patients with BM were compared to those included in the identified PRO measures.


      A total of 34 concepts and seven key PRO measures used in BM (Functional Assessment of Cancer Therapy- General [FACT-G], FACT-Brain Tumor [FACT-Br], FACT-Brain Symptom Index [FBrSI], European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire [EORTC-QLQ-C30], EORTC-Brain cancer module [EORTC QLQ-BN20], the EORTC- palliative care cancer module [EORTC QLQ-C15-PAL] and the M.D. Anderson Symptom Inventory-Brain Tumor Module [MDASI-BT]) were reviewed. The major limitation of all measures reviewed is that the items of these measures were not developed based on qualitative interviews with BM patients. In addition, these measures include concepts that were not related to BM per se as identified in the literature (e.g. itchy skin); some concepts found in the literature were not included in these instruments (e.g. dizziness).


      Review of the seven PRO measures used in patients with BM found that none of the measures have documented patient input in their development. The gaps between concepts reported in the literature and the PRO measures suggest the need for direct patient input in development of such measures in order to be comprehensive and yet specific to the target population.