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Robust assessment of cancer patients' physical symptoms, the side effects of treatment and their impact on daily functioning and well-being is essential for modern oncology practice. Many cancer treatments have a narrow therapeutic range with often significant toxicity and small clinical benefits. The traditional medical interview to elicit symptoms and the formal recording of adverse events in clinical trials using the Common Terminology Criteria for Adverse Events (CTCAE) can be supplemented by structured symptom and functional information derived directly from patients.

Patient-reported outcome measures (PROMs) are defined as 'any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else'.1 PROMs provide a formal measurement of the subjective phenomena that make up the patient's perception of symptoms, daily functioning and health-related quality of life (HRQOL) and they carry important information on care quality. They can be measured using carefully developed and validated questionnaires. These measures can be applied in clinical trials to compare patient outcomes, in routine oncology practice to support patient care, and in population surveys.

The first PROMs used in oncology were HRQOL questionnaires. These multidimensional questionnaires measure physical symptoms, psychological distress, the impact on daily functioning and patient perceptions of their quality of life (QOL) and well-being.2-5 More recently, a movement towards including patient voices in drug safety evaluations has focused on robust assessment of physical symptoms and side effects in clinical trials. This led to the development by the National Cancer Institute of a patient-reported outcomes version of the CTCAE system, known as the PRO-CTCAE.6 In parallel, aspirations to provide better patient-centred care recommended PROMs for holistic needs assessment of all cancer patients, using screening tools such as the Distress Thermometer and Concerns Checklist.

PROMs in oncology trials

Traditionally PROMs, specifically HRQOL questionnaires, have been used in oncology trials as secondary outcome measures in addition to cancer outcomes such as overall or progression-free survival. This approach provided valuable information on side effects and patients' experiences with new treatments. Systematic reviews show that the measurement of HRQOL supported clinical decision making in a range of clinical trials.7

In an important recent example, the Prostate Testing for Cancer and Treatment (ProtecT) trial randomized 1643 men diagnosed by prostate-specific antigen levels to active monitoring, radical surgery or radiotherapy. PROMs were collected on urinary, bowel and sexual functions, and their effects on QOL. Urinary and sexual functioning were better in patients managed by active monitoring or radiotherapy (Figure 2.1), but general HRQOL scores were equivalent.8 Given that the 10 year survival was equivalent, robust PROMs data will have a major influence on shared decision making, patient management and policy.

Figure 2.1

Example of use of PROMs data in the ProtecT trial. (A) Patient-reported effect of treatment on continence. (B) Patient-reported effect ...

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