The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline

•This ESMO Guideline provides key recommendations on the role of PROMs during the care of patients with cancer.•It covers the use of PROMs in patients with cancer from the start of active treatment during follow-up to the end of life.•Recommendations are based on available scientific evidence and the authors’ collective expert consensus.•Authorship includes a multidisciplinary group of experts from Europe, North America, Asia and Australia. IntroductionPatients with cancer frequently experience symptoms related to their disease or treatment-related toxicities. Symptom management through optimal supportive care is a foundation of quality care. While objective toxicities and laboratory results are amenable to reporting by health care personnel, subjective experiences such as symptoms are best reported by patients themselves.1Di Maio M. Basch E. Bryce J. et al.Patient-reported outcomes in the evaluation of toxicity of anticancer treatments.Nat Rev Clin Oncol. 2016; 13: 319-325Crossref PubMed Scopus (128) Google Scholar Traditionally, patients are relied upon to discuss symptoms and side-effects with the clinical team during hospital and clinic visits, when contacting their health care team between visits via telephone or, more recently, electronic messaging.Prior research indicates that health care providers often under-detect symptoms or underestimate their severity.2Laugsand E.A. Sprangers M.A.G. Bjordal K. et al.Health care providers underestimate symptom intensities of cancer patients: a multicenter European study.Health Qual Life Outcomes. 2010; 8: 104Crossref PubMed Scopus (189) Google Scholar, 3Basch E. Iasonos A. McDonough T. et al.Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study.Lancet Oncol. 2006; 7: 903-909Abstract Full Text Full Text PDF PubMed Scopus (415) Google Scholar, 4Basch E. The missing voice of patients in drug-safety reporting.N Engl J Med. 2010; 362: 865-869Crossref PubMed Scopus (414) Google Scholar, 5Marino D. Baratelli C. Guida G. et al.Impact of adoption of patient-reported outcomes in clinical practice on the accuracy of symptom reporting in medical records of cancer patients.Recenti Prog Med. 2020; 111: 740-748Google Scholar, 6Greimel E.R. Bjelic-Radisic V. Pfisterer J. et al.Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials.Support Care Cancer. 2010; 19: 1421-1427Crossref Scopus (20) Google Scholar This is especially true when side-effects or symptoms are not life-threatening4Basch E. The missing voice of patients in drug-safety reporting.N Engl J Med. 2010; 362: 865-869Crossref PubMed Scopus (414) Google Scholar although impacting quality of life (QoL). Prior publications demonstrate a lack of concordance between symptom recognition by clinicians and patient self-reporting.3Basch E. Iasonos A. McDonough T. et al.Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study.Lancet Oncol. 2006; 7: 903-909Abstract Full Text Full Text PDF PubMed Scopus (415) Google Scholar,7Strömgren A.S. Groenvold M. Sorensen A. et al.Symptom recognition in advanced cancer. A comparison of nursing records against patient self-rating.Acta Anaesthesiol Scand. 2001; 45: 1080-1085Crossref PubMed Scopus (0) Google Scholar, 8Coombes R.C. Bliss J. Hall E. et al.Under-reporting of symptoms in patients with early breast cancer who have received tamoxifen treatment for 2–3 years.Proc Am Soc Clin Oncol. 2003; 22: 48Google Scholar, 9Di Maio M. Gallo C. Leighl N.B. et al.Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials.J Clin Oncol. 2015; 33: 910-915Crossref PubMed Scopus (262) Google Scholar For instance, in one large clinical trial patients rated several tamoxifen-related symptoms (hot flushes, weight gain, night sweats, sleeping difficulties and loss of libido) as severe, but concordance of these with clinicians’ recordings at any severity was less than expected by chance.8Coombes R.C. Bliss J. Hall E. et al.Under-reporting of symptoms in patients with early breast cancer who have received tamoxifen treatment for 2–3 years.Proc Am Soc Clin Oncol. 2003; 22: 48Google Scholar Likewise, in 1090 patients with breast or lung cancer included in three randomised trials, the reporting of significant chemotherapy (ChT)-related toxicity (all symptoms analysed), e.g. diarrhoea, nausea, anorexia were under-reported by clinicians in terms of incidence and severity.9Di Maio M. Gallo C. Leighl N.B. et al.Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials.J Clin Oncol. 2015; 33: 910-915Crossref PubMed Scopus (262) Google Scholar Suboptimal symptom detection by clinicians can potentially lead to delayed or suboptimal management and may affect adherence to therapies, symptom control, patient QoL and survival.Reasons for discrepancies between reports by clinicians and patients may include a failure to ask questions systematically, time constraints of busy clinic visits and attribution bias (focusing only on expected or serious adverse events rather than symptoms the patient may be experiencing).10Fellowes D. Fallowfield L.J. Saunders C.M. et al.Tolerability of hormone therapies for breast cancer: how informative are documented symptom profiles in medical notes for ‘well-tolerated’ treatments?.Breast Cancer Res Treat. 2001; 66: 73-81Crossref PubMed Scopus (0) Google Scholar Additionally, patients may feel hesitant to mention certain symptoms or worry that treatment might be stopped if they express complaints.11Dai Y. Cook O.Y. Yeganeh L. et al.Patient-reported barriers and facilitators to seeking and accessing support in gynecologic and breast cancer survivors with sexual problems: a systematic review of qualitative and quantitative studies.J Sex Med. 2020; 17: 1326-1358Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar Patients also report difficulty remembering symptoms experienced between clinic visits.12Beaver C. Magnan M. Managing chemotherapy side effects: achieving reliable and equitable outcomes.Clin J Oncol Nurs. 2016; 20: 589-591Crossref Scopus (17) Google Scholar,13Coolbrandt A. Van den Heede K. Vanhove E. et al.Immediate versus delayed self-reporting of symptoms and side effects during chemotherapy: does timing matter?.Eur J Oncol Nurs. 2011; 15: 130-136Abstract Full Text Full Text PDF PubMed Scopus (38) Google ScholarSymptom monitoring via patient-reported outcomes (PROs) offers an evidence-based approach to detecting symptoms which can provide critical information to clinicians, thereby improving clinical management. PROs 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’.14U.S. Department of Health Human Services F.D.A. Center for Drug Evaluation Research, U.S. Department of Health Human Services F.D.A. Center for Biologics Evaluation Research, U.S. Department of Health Human Services F.D.A. Center for Devices Radiological HealthGuidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.Health Qual Life Outcomes. 2006; 4: 79Crossref Scopus (984) Google Scholar Patient-reported outcome measures (PROMs) are tools and/or instruments used to report PROs, usually questionnaires (although they can include standardised interview schedules), to assess elements of their experience such as symptom burden, functional status and psychological and emotional well-being.15Warrington L. Absolom K. Conner M. et al.Electronic systems for patients to report and manage side effects of cancer treatment: systematic review.J Med Internet Res. 2019; 21: e10875Crossref PubMed Scopus (58) Google Scholar In clinical practice, PROMs can be used to foster communication between patients and clinicians, assist in the detection and management of treatment toxicities and disease progression or recurrence and facilitate optimal delivery of supportive care.1Di Maio M. Basch E. Bryce J. et al.Patient-reported outcomes in the evaluation of toxicity of anticancer treatments.Nat Rev Clin Oncol. 2016; 13: 319-325Crossref PubMed Scopus (128) Google Scholar,16Yang L.Y. Manhas D.S. Howard A.F. et al.Patient-reported outcome use in oncology: a systematic review of the impact on patient-clinician communication.Support Care Cancer. 2017; 26: 41-60Crossref Scopus (89) Google ScholarThe opportunity to use PROMs completed by patients and received by nurses and/or doctors enables timely and systematic assessment of clinical trends of symptoms and side-effects.17Marandino L. Necchi A. Aglietta M. et al.COVID-19 emergency and the need to speed up the adoption of electronic patient-reported outcomes in cancer clinical practice.JCO Oncol Pract. 2020; 16: 295-298Crossref PubMed Scopus (25) Google Scholar The use of electronic systems for administering PROMs to patients with cancer and communicating this information back to their clinicians has been shown to improve symptom control, physical function, QoL, adherence to treatment, reduction in emergency room and hospital admissions and survival.18Basch E. Deal A.M. Kris M.G. et al.Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.J Clin Oncol. 2016; 34: 557-565Crossref PubMed Scopus (1110) Google Scholar, 19Basch E. Deal A.M. Dueck A.C. et al.Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment.JAMA. 2017; 318: 197-198Crossref PubMed Scopus (937) Google Scholar, 20Basch E. Schrag D. Jansen J. et al.Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.J Clin Oncol. 2021; 39: 349527Crossref Google Scholar, 21Barbera L. Sutradhar R. Seow H. et al.Impact of standardized Edmonton symptom assessment system use on emergency department visits and hospitalization: results of a population-based retrospective matched cohort analysis.JCO Oncol Pract. 2020; 16: e958-e965Crossref Scopus (21) Google Scholar, 22Barbera L. Sutradhar R. Seow H. et al.The impact of routine Edmonton Symptom Assessment System (ESAS) use on overall survival in cancer patients: Results of a population-based retrospective matched cohort analysis.Cancer Med. 2020; 9: 7107-7115Crossref Scopus (19) Google ScholarUse of PROMs in patients undergoing active cancer treatmentClinical scenariosFor patients receiving curative therapy (e.g. definitive, adjuvant or neoadjuvant), the treatment goal is to eradicate the disease. In such patients, combined modality therapy is common, and patients often receive intensive treatments that produce considerable toxicity. These include organ-preserving regimens, such as definitive radiotherapy (RT) combined with radio-sensitising ChT (as in the treatment of head and neck, anal, lung and cervical cancers), adjuvant therapy following radical surgery (as in breast, colon and lung cancers) or neoadjuvant chemoradiotherapy preceding radical surgery (as in oesophageal and rectal cancer). The morbidity of each treatment is often magnified because of overlapping toxicity. In this setting, however, clinicians and patients may be willing to tolerate the intensity and severity of symptoms in hopes of achieving a cure. Using PROMs to describe the severity and type of symptoms can help identify symptoms that would benefit from supportive interventions, determine the recovery time needed to return to usual activities and prepare future patients for what to expect during and after treatment. Automated advice feedback to the patient can facilitate self-management at home, particularly for milder symptoms detected by PROMs.23Absolom K. Warrington L. Hudson E. et al.Phase III randomized controlled trial of eRAPID: eHealth intervention during chemotherapy.J Clin Oncol. 2021; 39: 734-747Crossref PubMed Scopus (49) Google ScholarPatients receiving RT with curative or palliative intent can experience acute toxicities, depending on the dose and schedule of treatment. These primarily occur in the field of treatment and can be severe. Fatigue can be a debilitating symptom during the later phases of RT treatments. PROMs could be used to monitor physical functioning and ability to complete usual activities in this setting and to anticipate and intervene in patients who may be deteriorating during the treatment and/or immediately following treatment.In the setting of advanced or metastatic disease, measurement of PROs is valuable for detecting symptoms and functional impairment associated with both disease and treatment. In these patients, for whom palliation is the primary goal of any intervention, regular assessment of PROs is central to informing clinical supportive management. Increasingly, patients with cancer are receiving systemic treatment over an extended period. These therapies include maintenance ChT or biological agents, endocrine therapies, targeted therapies, immunotherapy and a combination of these. When treatments are expected to last for many months or even years, side-effects that impact QoL, even at a low level, are more likely to result in non-adherence. Regular measurement of PROs permits early identification of the difficulties patients are experiencing and offers opportunities to discuss modified dosing and supportive care.PROMs that monitor symptoms and physical functioning can also address post-treatment and survivorship concerns. Some persisting symptoms such as pain, fatigue, sleep disturbance, cognitive difficulties, distress, depression and sexual issues are important to measure in the post-treatment period.Evidence supporting the adoption of PROMs in clinical practiceProspective trials and population-based studies have demonstrated improved outcomes when electronic PROMs are implemented for monitoring patients during routine cancer treatment with systemic therapies, including improvements in physical function, symptom control, health-related QoL, hospitalisations, overall survival (OS), patient satisfaction and cost-effectiveness15Warrington L. Absolom K. Conner M. et al.Electronic systems for patients to report and manage side effects of cancer treatment: systematic review.J Med Internet Res. 2019; 21: e10875Crossref PubMed Scopus (58) Google Scholar,18Basch E. Deal A.M. Kris M.G. et al.Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.J Clin Oncol. 2016; 34: 557-565Crossref PubMed Scopus (1110) Google Scholar, 19Basch E. Deal A.M. Dueck A.C. et al.Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment.JAMA. 2017; 318: 197-198Crossref PubMed Scopus (937) Google Scholar, 20Basch E. Schrag D. Jansen J. et al.Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.J Clin Oncol. 2021; 39: 349527Crossref Google Scholar, 21Barbera L. Sutradhar R. Seow H. et al.Impact of standardized Edmonton symptom assessment system use on emergency department visits and hospitalization: results of a population-based retrospective matched cohort analysis.JCO Oncol Pract. 2020; 16: e958-e965Crossref Scopus (21) Google Scholar, 22Barbera L. Sutradhar R. Seow H. et al.The impact of routine Edmonton Symptom Assessment System (ESAS) use on overall survival in cancer patients: Results of a population-based retrospective matched cohort analysis.Cancer Med. 2020; 9: 7107-7115Crossref Scopus (19) Google Scholar, 23Absolom K. Warrington L. Hudson E. et al.Phase III randomized controlled trial of eRAPID: eHealth intervention during chemotherapy.J Clin Oncol. 2021; 39: 734-747Crossref PubMed Scopus (49) Google Scholar, 24Kotronoulas G. Kearney N. Maguire R. et al.What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials.J Clin Oncol. 2014; 32: 1480-1501Crossref PubMed Google Scholar, 25Lizée T. Basch E. Trémolières P. et al.Cost-effectiveness of web-based patient-reported outcome surveillance in patients with lung cancer.J Thorac Oncol. 2019; 14: 1012-1020Abstract Full Text Full Text PDF PubMed Google Scholar, 26Nixon N.A. Spackman E. Clement F. et al.Cost-effectiveness of symptom monitoring with patient-reported outcomes during routine cancer treatment.J Cancer Policy. 2018; 15: 32-36Crossref Google Scholar (Figure 1). Common features of the electronic PROM systems used in these studies include the availability of PRO questions via the web, handheld devices and/or automated telephone systems, inclusion of questions for common cross-cutting PROs from prior research (e.g. pain, nausea, vomiting, constipation, diarrhoea, dyspnoea, insomnia, depression and physical function), electronic prompts and reminders to self-report via email, text or automated telephone, use of validated symptom questions based on prior research and automated alerts to clinicians for severe or worsening symptoms. Multiple academic and commercial systems are available that include these features.A 2014 systematic review of controlled trials evaluated whether the inclusion of PROMs in routine clinical practice was associated with improvements in patient outcomes, processes of care and health service outcomes during active cancer treatment.24Kotronoulas G. Kearney N. Maguire R. et al.What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials.J Clin Oncol. 2014; 32: 1480-1501Crossref PubMed Google Scholar Studies were heterogeneous in terms of settings and methods: some used paper-based tools in the clinic, whereas others used electronic tools at home. In some studies, the use of PROMs was associated with improved symptom control, increased supportive care measures and patient satisfaction, although with limited statistically significant findings and predominantly small-to-moderate effect sizes.Subsequently, several randomised controlled trials (RCTs) tested remote monitoring by electronic PROM web applications in patients undergoing active cancer treatment of different types of cancer18Basch E. Deal A.M. Kris M.G. et al.Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.J Clin Oncol. 2016; 34: 557-565Crossref PubMed Scopus (1110) Google Scholar, 19Basch E. Deal A.M. Dueck A.C. et al.Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment.JAMA. 2017; 318: 197-198Crossref PubMed Scopus (937) Google Scholar, 20Basch E. Schrag D. Jansen J. et al.Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.J Clin Oncol. 2021; 39: 349527Crossref Google Scholar,23Absolom K. Warrington L. Hudson E. et al.Phase III randomized controlled trial of eRAPID: eHealth intervention during chemotherapy.J Clin Oncol. 2021; 39: 734-747Crossref PubMed Scopus (49) Google Scholar,27Berry D.L. Hong F. Halpenny B. et al.Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.J Clin Oncol. 2014; 32: 199-205Crossref PubMed Scopus (118) Google Scholar, 28Strasser F. Blum D. von Moos R. et al.The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MO AIC, a multicenter cluster-randomized phase III study (SAKK 95/06).Ann Oncol. 2016; 27: 324-332Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar, 29Mir O. Ferrua M. Fourcade A. et al.Intervention combining nurse navigators (NNs) and a mobile application versus standard of care (SOC) in cancer patients (pts) treated with oral anticancer agents (OAA): Results of CapRI, a single-center, randomized phase III trial.J Clin Oncol. 2020; 38: 2000Crossref Google Scholar, 30Mooney K. Iacob E. Wilson C.M. et al.Randomized trial of remote cancer symptom monitoring during COVID-19: impact on symptoms, QoL, and unplanned health care utilization.J Clin Oncol. 2021; 39: 12000Crossref Google Scholar (see Table 1 for details on the questionnaires and software used within each trial).Table 1Most relevant randomised studies of remote monitoring by ePRO web application in patients undergoing active cancer treatment (any type of cancer)aSee Supplementary Table S1, available at https://doi.org/10.1016/j.annonc.2022.04.007 for relevant references and information on electronic medical record systems that have been used for symptom monitoring during usual care.Author, yearNumber of patientsSettingQuestionnaires usedSoftwareMulticentric trialImproved outcomeBerry L, 201427Berry D.L. Hong F. Halpenny B. et al.Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.J Clin Oncol. 2014; 32: 199-205Crossref PubMed Scopus (118) Google Scholar752Patients with cancer, any stage (about 1/3 metastatic), starting a new therapeutic regimeSDS-15ESRA-CYesSymptom controlStrasser F, 201628Strasser F. Blum D. von Moos R. et al.The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MO AIC, a multicenter cluster-randomized phase III study (SAKK 95/06).Ann Oncol. 2016; 27: 324-332Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar264Patients with advanced cancer, receiving ChTESASE-MOSAIC, (generating a LoMoS)YesSymptom controlBasch E, 201618Basch E. Deal A.M. Kris M.G. et al.Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.J Clin Oncol. 2016; 34: 557-565Crossref PubMed Scopus (1110) Google Scholar,19Basch E. Deal A.M. Dueck A.C. et al.Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment.JAMA. 2017; 318: 197-198Crossref PubMed Scopus (937) Google Scholar766Patients with metastatic cancer, initiating ChTNCI-CTCAESTARNoQoL/OS/reduced emergency useMir O, 202029Mir O. Ferrua M. Fourcade A. et al.Intervention combining nurse navigators (NNs) and a mobile application versus standard of care (SOC) in cancer patients (pts) treated with oral anticancer agents (OAA): Results of CapRI, a single-center, randomized phase III trial.J Clin Oncol. 2020; 38: 2000Crossref Google Scholar609Patients with advanced cancer, receiving oral treatment (except hormonal therapy)PRO-CTCAECAPRI RPMSNoDose intensity/reduction in hospitalisationAbsolom K, 202123Absolom K. Warrington L. Hudson E. et al.Phase III randomized controlled trial of eRAPID: eHealth intervention during chemotherapy.J Clin Oncol. 2021; 39: 734-747Crossref PubMed Scopus (49) Google Scholar508Patients with cancer, all stages (62.4% primary or local), initiating systemic treatment (ChT with or without targeted therapies)NCI-CTCAEeRAPIDNoQoL/symptom controlMooney K, 202130Mooney K. Iacob E. Wilson C.M. et al.Randomized trial of remote cancer symptom monitoring during COVID-19: impact on symptoms, QoL, and unplanned health care utilization.J Clin Oncol. 2021; 39: 12000Crossref Google Scholar252Patients with cancer, any stage, receiving ChT and/or RTMDASI and NIH PROMISSCHNoQoL/symptom control/reduction in unplanned health care episodesBasch E, 202120Basch E. Schrag D. Jansen J. et al.Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.J Clin Oncol. 2021; 39: 349527Crossref Google Scholar1191Patients with advanced cancer, receiving systemic therapyPRO-CTCAEPRO-TECT digital ePRO systemYesQoL/symptom control/physical functionCAPRI RPMS, Cancerologie Parcours Région Ile de France Remote Patient Monitoring Systems; ChT, chemotherapy; E-MOSAIC, electronic monitoring of symptoms and syndromes associated with cancer; ePRO, electronic patient-reported outcome; eRAPID, electronic patient self-reporting of adverse-events: patient information and advice; ESAS, Edmonton Symptom Assessment System; ESRA-C Electronic Self-Report Assessment-Cancer; LoMoS, longitudinal monitoring sheet; MDASI, MD Anderson Symptom Inventory; NCI-CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events; NIH PROMIS, National Institute of Health Patient-Reported Outcomes Measurement Information System; OS, overall survival; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; QoL, quality of life; RT, radiotherapy; SCH, Symptom Care at Home; SDS, Symptom Distress Scale; STAR, Symptom Tracking and Reporting.a See Supplementary Table S1, available at https://doi.org/10.1016/j.annonc.2022.04.007 for relevant references and information on electronic medical record systems that have been used for symptom monitoring during usual care. Open table in a new tab In the seminal trial conducted at Memorial Sloan Kettering Cancer Center, 766 patients receiving routine outpatient ChT for advanced solid tumours were randomised to either receive usual care (consisting of symptom monitoring at clinicians’ discretion) or to report 12 common symptoms via a remote system at home or on tablets or computers in the hospital waiting room.18Basch E. Deal A.M. Kris M.G. et al.Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.J Clin Oncol. 2016; 34: 557-565Crossref PubMed Scopus (1110) Google Scholar Self-reporting was conducted via the web-based interface STAR (Symptom Tracking and Reporting), and included questions adapted for patient use from the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), pertaining to 12 common symptoms experienced during ChT, graded on a five-point scale from 0 (not present) to 4 (disabling). STAR did not allow skipped questions or free-text responses. Nurses received e-mail alerts when participants reported severe or worsening symptoms, and treating physicians received symptom printouts at visits. Symptom monitoring was associated with significantly improved QoL, reduction in emergency room admissions and hospitalisations. In addition, analysis of OS found a significant prolongation of life with the use of the reporting system.19Basch E. Deal A.M. Dueck A.C. et al.Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment.JAMA. 2017; 318: 197-198Crossref PubMed Scopus (937) Google ScholarThe PRO-TECT cluster randomised trial, conducted at 52 United States community oncology practice centres, compared digital symptom monitoring with PROMs (treatment arm) with usual care (control) in 1191 patients with metastatic cancer receiving active treatment.20Basch E. Schrag D. Jansen J. et al.Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.J Clin Oncol. 2021; 39: 349527Crossref Google Scholar Patients in the treatment arm were invited to complete a weekly survey via the web or an automated telephone system for up to 1 year, which included items from the PRO version of the CTCAE about common symptoms, as well as performance status, financial toxicity and falls. The digital PRO-TECT electronic PRO (ePRO) system used in the study was built by the University of North Carolina’s PROs Core. Severe or worsening symptoms triggered electronic alerts to care team nurses and reports showing the trend of symptoms over time were available to oncologists at visits. Mean changes from baseline were significantly better with digital monitoring for physical function, symptom control and health-related QoL. Clinically meaningful benefits were experienced by 13.8% more patients with digital monitoring versus control in physical function, 16.1% in symptom control and 13.4% in QoL. Additional outcomes such as effects on hospitalisations and survival have not yet been reported.Although RCTs represent the highest level of evidence supporting the efficacy of PROM implementation, important evidence comes also from real-world data and non-randomised studies. A population-based, retrospective, matched cohort analysis examined the effect of the exposure to the Edmonton Symptom Assessment System (ESAS) on patient survival, rates of emergency visits and hospitalisations. The ESAS is a validated instrument to measure symptoms among ambulatory cancer patients, the use of which has been standardised in the Ontario cancer practice network.21Barbera L. Sutradhar R. Seow H. et al.Impact of standardized Edmonton symptom assessment system use on emergency department visits and hospitalization: results of a population-based retrospective matched cohort analysis.JCO Oncol Pract. 2020; 16: e958-e965Crossref Scopus (21) Google Scholar,22Barbera L. Sutradhar R. Seow H. et al.The impact of routine Edmonton Symptom Assessment System (ESAS) use on overall survival in cancer patients: Results of a population-based retrospective matched cohort analysis.Cancer Med. 2020; 9: 7107-7115Crossref Scopus (19) Google Scholar The analysis, conducted in 128 893 pairs of patients with cancer between 2007 and 2015, showed improved survival and reduced rates of emergency vis