Patient-Reported Outcomes in Ovarian Cancer: Facilitating and Enhancing the Reporting of Symptoms, Adverse Events, and Subjective Benefit of Treatment in Clinical Trials and Clinical Practice

Figures & data

Box 1 Benefits of Assessing PROs in Ovarian Cancer Clinical Trials versus Clinical Practice

Clinical Trials versus Clinical Practice

PRO data collected in clinical trials can be used to: Influence changes to clinical practice guidelines and provide information to support drug approval and pharmaceutical labelling claims;^Citation2,Citation3 Help patients make decisions about treatment with their clinician, based on what others in similar situations have experienced (ie the possible and likely treatment effects);^Citation5 Enhance clinician understanding of treatment benefits and harms during the acute treatment and survivorship phase, helping them communicate realistic expectations to patients about the likely impact of treatment on daily life;^Citation5 At baseline, serve as an independent prognostic factor for survival and be used to improve clinical trial methodology. Eg to inform clinical trial eligibility criteria or to stratify patients into trial arms.^Citation5–10

PRO data collected in clinical practice can be used to: Monitor a patient’s symptoms over time throughout treatment and survivorship;^Citation3,Citation11 Guide an individual patient’s clinical management eg decisions about dose reduction or escalation, or cessation of treatment;^Citation4 Screen and identify patients most likely to benefit from referral to psychosocial or supportive care;^Citation11,Citation12 Facilitate communication between the patient and their managing clinician about their symptoms and how they are impacting their HRQL.^Citation12 Help ensure patients and clinicians discuss sensitive topics (eg sexual or mental health issues) that may otherwise be overlooked in an unstructured clinical consultation.^Citation11 Facilitate communication regarding likely prognosis and help decision-making in women considering further chemotherapy.^Citation13–15

Figure 1 Relevant PROs to assess throughout the disease and treatment trajectory in ovarian cancer clinical trials and clinical practice.

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