PRO-cision Medicine: Personalizing Patient Care Using Patient-Reported Outcomes.

Abstract

In the article that accompanies this editorial, Basch et al report findings from a study that randomly assigned 766 patients with cancer receiving outpatient chemotherapy for metastatic disease to routine electronic patient reporting of 12 common symptoms or to usual care (symptom monitoring at the clinician’s discretion). Patients were stratified by computer experience (regular computer access and at least weekly e-mail use v less use). All patients were invited to report on their symptoms at clinic visits, with the computerexperienced group also receiving e-mails inviting them to report on their symptoms between visits. Participants were observed for 6 months, with the primary outcome of change in health-related quality of life (HRQL) from baseline measured by the EuroQol EQ-5D index. Secondary outcomes included emergency room (ER) visits, hospitalizations, and survival. The authors found that the HRQL of patients in the intervention group, compared with the control group, was more likely to improve (34% v 18%, respectively) and less likely to worsen (38% v 53%, respectively) (P , .001). In addition, intervention patients, compared with control patients, were less likely to be admitted to the ER (34% v 41%, respectively; P5 .02), remained on chemotherapy longer (8.2 v 6.3months, respectively; P5.002), were more likely to survive 1 year (75% v 69%, respectively; P5 .05), and had better quality-adjusted survival (8.7 v 8.0 months, respectively; P5.004). Although not statistically significant, intervention patients were also less likely to be hospitalized compared with control patients (45% v 49%, respectively; P 5 .08). Notably, the benefits found in the study sample as a whole were more pronounced in the computer-inexperienced subgroup. The strengths of this study are the large patient cohort, the inclusion of both patient-reported outcomes (PROs) and health service outcomes in addition to survival, and a unique study design that stratifies participants by computer experience. Notably, random assignment occurred at the patient level, meaning that the clinicians in this study were managing both intervention and control patients. If clinicians’ use of the PRO report with intervention patients influenced their care of control patients, the impact would bias the findings toward the null, suggesting that this study’s significant positive outcomesmay underestimate the intervention’s true benefit. Although the study was conducted in a single center, the inclusion of multiple cancer types improves its generalizability. This study makes important contributions to the growing literature demonstrating the value of routine PRO assessment. PROs are any report coming directly from patients about a disease, health, or treatment without interpretation by a clinician or anyone else. They include a range of outcomes, such as HRQL, symptoms, functional status, andwell-being. AlthoughPROs are commonly used as outcome measures in clinical trials, there is increasing interest in using them for individual patient management, with a number of electronic PRO monitoring systems being developed for this purpose. Randomized clinical trials examining PRO monitoring in cancer have consistently shown improvements in patient-provider communication, but benefits regarding improved symptommanagement, broader HRQL, health outcomes, and care utilization have been harder to demonstrate. Several notable aspects of this study’s design may provide insight regarding factors associated with its positive outcomes. First, in this study, patients rated 12 symptoms from the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events as none, mild, moderate, severe, or disabling. Given clinicians’ familiarity with symptom management, this symptom focus and straightforward rating may be easier for clinicians to understand and, thereby, inform patient care. Even though symptoms and adverse effects are commonly covered during patient visits as part of usual care, this study found that systematic collection and reporting resulted in not only better HRQL but also fewer ER visits and improved survival, emphasizing the importance of standardized PRO assessment. This finding is supported by a Canadian retrospective study that also found significantly lower ER visits among chemotherapy patients completing in-clinic symptom PRO assessments. These findings are important for clinicians who may question the need for routine PRO symptom assessments because they screen for symptoms in practice. An important question for further exploration is whether this impact of routine PRO assessments extends beyond specific symptoms to function and well-being (eg, physical, mental, social). Although clinicians may be less familiar with these outcomes and how to manage them, these outcomes are also less likely to be covered in routine practice and, therefore, may have even greater potential to add value to patient care. Second, the target population for this study was patients with metastatic cancer receiving chemotherapy. The authors specifically