Pathology

EQ-5D

Disease

Quality of life (healthcare)

Nursing

Political science

Physical therapy

Psychology

Patient satisfaction

Judgement

Popularity

Patient-reported outcome

Health related quality of life

Clinical trial

Medicine

Social psychology

BMJ evidence-based medicine

In recent years, patient-reported outcome measures (PROMs) have become increasingly popular in clinical practice and clinical trials. In this paper, we highlight the need for introducing measures to control for the bias associated with these inherently subjective measures and combining PROMs with objective outcomes, which do not depend on judgement, experience or performance.PROMs measure the subjective elements of patients’ conditions, including health-related quality of life, pain intensity, activity limitations, participation restrictions, satisfaction or adherence to treatment and help to evaluate the burden of disease and treatment from patients’ perspectives.1Originally, PROMs were used in pharmacological research to assess treatment effects in conditions such as cancer, in cases where the cure was not possible, and quality of life became the primary concern.2 In the last 20 years, the use of PROMs has increased considerably,1 3 and, currently, those outcomes are used to assess the effects of treatment and quality of care2 and to evaluate policies3 and to inform health economics.4 One of the factors that contributed to the popularity of PROMs was their recognition by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a measure of treatment efficacy.1 5 6 The FDA and the EMA define PROMs as any outcomes related to the patient’s health or treatment that is evaluated directly by the patient, without any interpretation by a doctor or anyone else.1 6 According to this definition, and in contrast to common perception, these outcomes do not necessarily measure what is the most important to patients or health itself.7 8### The role of PROMsThe main role of PROMs …

Patient-reported outcome measures (PROMs) as proof of treatment efficacy