Recording patient-reported outcomes electronically in real time and allowing clinicians to review longitudinal PRO reports can improve patients' quality of life, enhance patient–clinician ...communication, reduce emergency department utilization, and lengthen survival.
Symptom management is a cornerstone of clinical care, particularly for patients with chronic conditions. Yet patients’ symptoms and physical impairments go undetected by health care providers as much as half the time, particularly between clinic visits.
1
As a result, we miss opportunities to intervene and alleviate suffering. Moreover, incomplete documentation of this information in the electronic health record (EHR) limits our ability to understand key patient outcomes when we aggregate EHR data for comparative effectiveness research or quality-of-care assessments.
2
Recent advances in technology and survey methods provide a potential solution in the form of patient-reported outcomes (PROs) recorded electronically — . . .
A drug label's “Adverse Reactions” section is based almost entirely on clinicians' impressions of patients' symptoms. Dr. Ethan Basch argues for collecting data directly from patients about symptoms ...they have while taking a drug.
A patient wants to know about symptoms she may have from a prescription drug she is taking. Consulting the label's “Adverse Reactions” section, she finds a wealth of data. Little does she realize that this information, largely collected during clinical trials, is based almost entirely on clinicians' impressions of patients' symptoms — not on patients' own firsthand reports of their experiences with the drug.
The current drug-labeling practice for adverse events is based on the implicit assumption that an accurate portrait of patients' subjective experiences can be provided by clinicians' documentation alone. Yet a substantial body of evidence contradicts this . . .
Regulators and industry continue to prioritize survival-based end points rather than patient-experience end points in cancer-drug development. Yet as patients live longer with cancer, they must ...increasingly choose among agents with varying efficacy–toxicity balances.
As an oncologist, when I sit with patients to discuss starting a new chemotherapy regimen, their first questions are often “How will it make me feel?” and “How did patients like me feel with this treatment?” Regrettably, this information is generally missing from U.S. drug labels and from published reports of clinical trials — the two information sources most commonly available to people trying to understand the clinical effects of cancer drugs.
In 2011, 15 hematology–oncology drugs were approved by the U.S. Food and Drug Administration (FDA). In only one case — that of ruxolitinib for the management of myelofibrosis . . .
Patient-reported outcomes (PROs) are data elements directly reported by patients or their surrogates about experiences with care, including symptoms, functional status, or quality of life. PROs have ...commonly been evaluated in clinical trials for drug and medical device development. Interest is growing in the ability to integrate PROs into additional contexts, particularly product safety evaluation, comparative effectiveness research, and measurement of care quality. This interest reflects a growing focus on patient-centeredness in health care broadly and on provisions of the US Patient Protection and Affordable Care Act of 2010. Multiple initiatives demonstrate the feasibility and value of patient reporting in these areas. Inclusion of PROs in electronic health records and hospital patient portals, as well as longitudinal registries, can facilitate use of these data for multiple analytic purposes as well as enhance delivery of care and patient-provider communication. Challenges include the logistics and cost of implementing PRO programs; missing data, particularly from hard-to-reach and ill patients; and the need for standardization of outcome measures and electronic data representation. These challenges have been surmounted in limited initiatives and now must be translated to larger implementations.
This Viewpoint proposes a framework for modifying cancer care in the midst of the COVID-19 pandemic that balances considerations about the time-sensitivity of patient need for visits and treatment, ...risk of infectious exposure, and hospital and staff capacity and stress.
Symptomatic toxicities associated with anticancer treatments, such as nausea and vomiting, are frequently underreported by clinicians, even when data are prospectively collected within clinical ...trials. Such underreporting can result in an underestimation of the absolute rate of toxicity, which is highly relevant information for patients and their physicians in clinical practice, and for regulatory authorities. Systematic collection of patient-reported outcomes (PROs) has been demonstrated to be a valid, reliable, feasible and precise approach to tabulating symptomatic toxicities and enables symptoms that are missed by clinicians to be detected. In this Perspectives, the barriers and challenges that should be addressed when considering broad integration of PRO toxicity monitoring in oncology clinical trials are discussed, including challenges related to data collection logistics, analytical approaches, and resource utilization. Instruments conceived to enable description of treatment-related adverse effects, from the patient perspective, bring the potential to improve risk-versus-benefit analyses in clinical research, and to provide patients with accurate information, on the basis of previous experiences of their peers.
Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical ...Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.
This Viewpoint discusses barriers to collecting patient-reported outcome measures for symptom monitoring as a component of the Oncology Care First payment model, a Centers for Medicare & Medicaid ...Services program that provides bundled population payments to cover physician services and enhancements intended to improve care quality for patients receiving systemic cancer treatment, and proposes ways to implement and facilitate the requirement given its importance to patient well-being.
Symptom monitoring during chemotherapy via web-based patient-reported outcomes (PROs) was previously demonstrated to lengthen survival in a single-center study.1 A multicenter randomized clinical ...trial compared web-based monitoring vs standard scheduled imaging to detect symptomatic recurrence in patients with lung cancer following initial treatment. A planned interim analysis (9-month follow-up) found a significant survival benefit (19-month survival in the PRO group vs 12 months in the control group).2 We now present the final overall survival analysis.
PDF
