PATIENT REPORTED OUTCOMES (PRO) IN ONCOLOGY, WHAT BEYOND RANDOMIZED CONTROLLED TRIALS?

Author(s)

Jarosławski S1, Toumi M1, Chouaid C2, Fallissard B3, Auquier P1
1Aix-Marseille University, Marseille, France, 2Department of Chest Medicine, Créteil University Hospital, Créteil, France, 3CESP, Univ. Paris-Sud, Université Paris-Saclay, UVSQ, INSERM U1178, Paris, France, Paris, France

OBJECTIVES: The use of PRO in oncology trials is increasing and the use of PRO in clinical trials translates into the use of PRO in FDA labels. We sought to review to what extent PRO data is used by doctors and patients in real-life settings. METHODS: Literature review. RESULTS: Many cancer-specific PRO instruments exist that have been developed to measure HRQL or symptoms relevant in a given cancer. Improvements in HRQL have been shown in treatment with certain biological therapies for cancers and PROs have been shown to correlate with survival in patients receiving cancer therapy. PROs are often better predictors of survival than performance status, but studies are needed to determine whether interventions that improve PROs also increase survival and to identify explanatory mechanisms through which PROs relate to survival. However, PROs are rarely used in non-trial settings. This means that oncologists cannot track patients progress or satisfaction with treatment in the clinic where PRO tools are not available. Also, clinicians may not understand the trade-offs the patients are willing to make between improvements in objective biological outcomes such as e.g. tumour shrinkage and possible worsening in other symptoms or HRQL. Therefore, the potential of PRO use beyond clinical trials remains underutilized. CONCLUSIONS: There is a need to develop a guidance and clinician training programs on the use of PRO tools in the clinic in order to utilise their potential to inform clinical decisions and to enhance the dialogue between the doctors and patients.

Conference/Value in Health Info

2018-09, ISPOR Asia Pacific 2018, Tokyo, Japan

Value in Health, Vol. 21, S2 (September 2018)

Code

PCP11

Topic

Health Policy & Regulatory

Disease

Oncology

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