Among patients receiving treatment for advanced cancers, symptoms are common and frequently cause distress, functional impairment, and emergency room visits. Yet cancer patients’ symptoms often go undetected and unaddressed by clinicians. There is growing international interest in integrating electronic patient-reported outcomes (PROs) into routine practice as digital therapeutics that can increase detection and inform management of symptoms, thereby improving health outcomes and patient experiences and avoiding preventable hospital use

Basch, E.

Dueck, A.C.

Mody, G.N.

Carolina Digital Repository

Electronic Patient-Reported Outcomes as DigitalTherapeutics to Improve Cancer OutcomesEthan Basch, MSc, MD1,2; Gita N. Mody, MPH, MD1,3; Amylou C. Dueck, PhD4Among patients receiving treatment for advancedcancers, symptoms are common and frequently causedistress, functional impairment, and emergency roomvisits.1 Yet cancer patients’ symptoms often go un-detected and unaddressed by clinicians.2-4 There isgrowing international interest in integrating electronicpatient-reported outcomes (PROs) into routine prac-tice as digital therapeutics that can increase detectionand inform management of symptoms, thereby im-proving health outcomes and patient experiences andavoiding preventable hospital use.PROs were initially developed to measure symptomsand functional impairments related to disease andtreatment in clinical research. More recently, they havebeen evaluated as routine practice symptom moni-toring tools in several prospective trials.5 The PROsymptommonitoring approach generally used in thesetrials involves a brief symptom questionnaire loadedinto a software package that patients can use to self-report from home or at clinic visits by using the Web,a smartphone app, or an automated telephone system.When severe or worsening symptoms are reported (eg,severe pain or dyspnea), the patient’s care team isinformed via an e-notification and/or via the electronicmedical record, reports, or some other secure me-dium. The care team can then intervene by addressingthe symptom early, before it worsens and leads todownstream complications.Previously, Velikova and colleagues6 reported a ran-domized controlled trial in which integrating PROsymptom monitoring into routine oncology ambulatoryvisits yielded significantly improved patient quality oflife compared with standard care. Cleeland and col-leagues7 found improved symptom control after can-cer surgery. Our group published a finding froma randomized controlled trial that showed significantlyimproved overall survival and reduced emergencyroom visits among patients with advanced solid tumorscompared with standard care. The improvements werelikely related to high rates of nursing intervention inresponse to PRO e-notifications, which resulted inbenefits in physical function and overall health status,along with lengthened tolerability of chemotherapy.8,9Denis and colleagues10 similarly reported overallsurvival benefits of using PRO symptom monitoring totrigger imaging in disease monitoring among patientswith lung cancer.Taken together, these trials paint a compelling pictureof the benefits of PRO symptom monitoring as a digitaltherapeutic strategy. However, previous research haslargely consisted of prospective studies that enrolledpatients via informed consent processes. Missing inthe published literature has been a large real-worldpopulation-based study in which all comers self-reported PROs across a large health system. Suchevidence has been needed to demonstrate the gen-eralizability of findings from previous controlled trials,thereby further justifying implementation in largepopulations.Barbera et al11 report just such evidence. In Ontario,Canada, the provincial government supported in-tegration of PROs into practice starting in 2007. Pa-tients with cancer seen at most sites of service inOntario were invited to report 9 common PROsymptoms at kiosks in clinic waiting areas immediatelybefore visits, and their self-reports were sharedwith care teams to inform the management of theirdisease. The study selected patients who self-reportedPROs at least once during an ambulatory visit be-tween 2007 and 2015. A comparator group of pa-tients who did not use PROs was generated by usinghard and propensity score matching. Among 128,893available matched patient pairs for the analysis, theauthors found a statistically significant 8% reduction inemergency room visits and a 14% reduction in hos-pitalizations for PRO patients compared with controlswho did not provide PROs. This finding is similar tothat in a previous randomized trial reporting a 7%reduction in emergency room visits associated withPROs.12On the basis of the article by Barbera et al, we nowhave evidence from both randomized trials and real-world assessments showing a substantial benefit ofPRO symptom monitoring for patients receiving sys-temic cancer treatment, presumably by catchingsymptoms early enough to avoid at least someemergency department visits and hospitalizations.The strength of this study is also its main limitation. Itwas conducted in a real-world population, so rates ofPRO reporting compliance varied. However, mostpatients completed more than 6 PRO self-reports, andalmost 20% completed more than 10 PRO self-reports. The comparison was not prospective orASSOCIATEDCONTENTSee accompanyingarticle on page 599Author affiliationsand supportinformation (ifapplicable) appearat the end of thisarticle.Accepted on April 23,2020 and published atascopubs.org/journal/op on June 2, 2020:DOI https://doi.org/10.1200/OP.20.00264randomized, but the authors used rigorous standard ap-proaches for matching and balancing groups. A formal costanalysis or granular report on use of services was notincluded.Future challenges are largely related to implementation.Amid competing priorities, how will oncology practices findbandwidth and resources to onboard PRO systems like theone used in previous trials and in the Barbera et al study?An essential component will be reimbursement by payers,because these entities will yield financial savings related toreduced hospital use. Indeed, in the United States, theMedicare program recently suggested including PROs ina proposed payment model in oncology.12 Medicare shouldtake this a step further and provide or expand a billing codeto enable payment for PRO symptommonitoring as a digitaltherapeutic. Private payers in the United States and non-USpayment mechanisms should follow suit. Surgical andpalliative care practices should adapt the lessons learnedfrom oncology to embrace PROs for symptommonitoring intheir highly vulnerable patient populations.It must be noted at this moment of crisis related to theCOVID-19 pandemic, that keeping patients out of the hos-pital is a key goal. PRO symptom monitoring as a strategycan contribute to achieving this goal, particularly if integratedwith a patient navigation and/or care coordination program.Moreover, as we widely shift oncology care to a virtual model,PRO symptom monitoring dovetails perfectly with othertelemedicine functionalities that allow us to stay connectedto patients when they are away from the clinic.Ontario has led the way for more than a decade in real-world implementation of PRO symptom monitoring in on-cology practice. With this study, Ontario continues its effortsby providing evidence of clinical and utilization benefits ofits digital therapeutic approach, likely yielding substantialcost savings to the health system and improving experi-ences for patients.AFFILIATIONS1Lineberger Comprehensive Cancer Center, University of North Carolina,Chapel Hill, NC2Division of Oncology, University of North Carolina, Chapel Hill, NC3Department of Surgery, University of North Carolina, Chapel Hill, NC4Mayo Clinic, Scottsdale AZCORRESPONDING AUTHOREthan Basch, MSc, MD, University of North Carolina, 170 Manning Dr,CB #7305, Chapel Hill, NC 27516; e-mail: ebasch@med.unc.edu.AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OFINTEREST AND DATA AVAILABILITY STATEMENTDisclosures provided by the authors and data availability statement (ifapplicable) are available with this article at DOI https://doi.org/10.1200/OP.20.00264.AUTHOR CONTRIBUTIONSConception and design: Ethan Basch, Gita N. ModyData analysis and interpretation: Ethan Basch, Amylou C. DueckManuscript writing: All authorsFinal approval of manuscript: All authorsAccountable for all aspects of the work: All authorsREFERENCES1. Henry DH, Viswanathan HN, Elkin EP, et al: Symptoms and treatment burden associated with cancer treatment: Results from a cross-sectional national surveyin the U.S. Support Care Cancer 16:791-801, 20082. Fromme EK, Eilers KM, Mori M, et al: How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms fromthe Quality-of-Life Questionnaire C30. J Clin Oncol 22:3485-3490, 20043. Laugsand EA, Sprangers MA, Bjordal K, et al: Health care providers underestimate symptom intensities of cancer patients: A multicenter European study.Health Qual Life Outcomes 8:104, 20104. Basch E, Iasonos A, McDonough T, et al: Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria forAdverse Events: Results of a questionnaire-based study. Lancet Oncol 7:903-909, 20065. Kotronoulas G, Kearney N, Maguire R, et al: What is the value of the routine use of patient-reported outcome measures toward improvement of patientoutcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol 32:1480-1501, 20146. Velikova G, Booth L, Smith AB, et al: Measuring quality of life in routine oncology practice improves communication and patient well-being: A randomizedcontrolled trial. J Clin Oncol 22:714-724, 20047. Cleeland CS, Wang XS, Shi Q, et al: Automated symptom alerts reduce postoperative symptom severity after cancer surgery: A randomized controlled clinicaltrial. J Clin Oncol 29:994-1000, 20118. Basch E, Deal AM, Dueck AC, et al: Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancertreatment. JAMA 318:197-198, 20179. Basch E, Deal AM, Kris MG, et al: Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. J ClinOncol 34:557-565, 201610. Denis F, Basch E, Septans AL, et al: Two-year survival comparing web-based symptom monitoring vs routine surveillance following treatment for lung cancer.JAMA 321:306-307, 201911. Barbera L, Sutradhar R, Seow H, et al: Impact of Standardized Edmonton Symptom Assessment System use on emergency department visits and hospi-talization: Results of a population-based retrospective matched cohort analysis. JCO Oncol Pract 16:e958-e964, 202012. Basch E, Wilfong L, Schrag D: Adding patient-reported outcomes toMedicare’s oncology value-based payment model. JAMA 10.1001/jama.2019.19970 [epubahead of print on January 2, 2020]Ethan BaschConsulting or Advisory Role: Sivan Innovation, Carevive Systems, NavigatingCancer, AstraZenecaOther Relationship: Centers for Medicare and Medicaid Services, NationalCancer Institute, American Society of Clinical Oncology, Journal of the AmericanMedical Association, Patient-Centered Outcomes Research InstituteOpen Payments Link: https://openpaymentsdata.cms.gov/physician/427875/summaryGita N. ModyConsulting or Advisory Role: iRenix Medical (I)Amylou C. DueckPatents, Royalties, Other Intellectual Property: Royalties from licensing fees fora patient symptom questionnaire (Myeloproliferative Neoplasm SymptomAssessment Form [MPN-SAF])No other potential conflicts of interest were reported.AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTERESTElectronic Patient-Reported Outcomes as Digital Therapeutics to Improve Cancer OutcomesThe following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I 5 Immediate Family Member, Inst 5 My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Electronic patient-reported outcomes as digital therapeutics to improve cancer outcomes

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Electronic patient-reported outcomes as digital therapeutics to improve cancer outcomes

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