FIT FOR PURPOSE REVIEW OF MEASURE OF DEPRESSION SYMPTOMS TO OBTAIN FDA PRO LABEL CLAIMS

Author(s)

Cheng R1, Cole JC2, Trivedi B2
1PPD, San Diego, CA, USA, 2ZS Associates, Thousand Oaks, CA, USA

OBJECTIVES:  A primary use for patient reported outcomes (PROs) is to measure latent states which are otherwise unmeasurable. As such, the CNS field offers a potpourri of disorders where the core of the disease must be measured via PRO. Depressive disorders are a quintessential CNS area where a number of PROs exist. However, since the 2006 draft guidance for PRO label claims was published, only two depressive disorders have obtained PRO label claims and neither of these were based on a measure of depression. The current study reviews the readiness of several commonly used depression measures to obtain a PRO-based label claim. METHODS:  Commonly used fit-for-purpose review tables were used to evaluate qualitative and quantitative readiness of the following PROs, which are either exclusively depression scales or include a subscale for depression: Beck Depression Inventory II (BDI-II), Quick Inventory of Depressive Symptomatology—Self Report (QIDS-SR), Outcome Questionnaire (OQ-45), Clinically Useful Depression Outcome Scale (CUDOS), Center for Epidemiologic Studies Depression Scale (CES-D), Patient Health Questionnaire (PHQ-9), Patient-Reported Outcomes Measurement Information System Depression Scale (PROMIS). RESULTS:  Although each of these scales has been used in medical and clinical research, virtually all of these scales have published qualitative research findings; many were developed before qualitative development approaches with patients were accepted practice. PROMIS Depression PRO meets most of the criteria but is strongest when used as an adaptive PRO, something the FDA has not yet endorsed. CONCLUSIONS:  Work needs to be done to come out with a multidimensional depression PRO that can be used for PRO-based label claims. The FDA PRO Consortium is developing a tool for this purpose. However, if pharmaceutical companies wish to obtain differentiated messages then additional PRO depression measures are likely to be required, such as one sees in rheumatic disorders.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PMH45

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Mental Health

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