Implementation Of Patient-reported Outcomes Research Articles

Integrating Patient-Reported Outcomes Into the Care of People With Advanced Cancer-A Practical Guide.

Patient-reported outcomes (PROs) are being increasingly integrated into routine clinical practice to enhance individual patient care. This has been driven by recognition of the benefits of PROs in enhancing symptom management, patient satisfaction, quality of life, and overall survival, and reductions in acute health care utilization. These benefits are reflected in the emergence of value-based health care initiatives incorporating PRO symptom monitoring such as the Enhancing Oncology Model in the United States. However, implementing PROs can be challenging and it can be difficult to know where to begin to select appropriate PROs, and effectively display and appropriately interpret PRO data. This manuscript summarizes an educational session at the 2024 ASCO Annual Meeting, which provided practical guidance to clinicians seeking to incorporate PROs into the care of people with advanced cancer. We focus on why it is important to collect PROs in routine care from a patient's perspective, how to select PROs for symptom monitoring (including using static patient-reported outcome measures and newer item libraries), and highlight key pearls and pitfalls in the display and interpretation of PROs. We highlight the breadth of existing resources available to guide clinicians in PRO implementation.

Understanding Health Equity in Patient-Reported Outcomes

Patient reported outcomes (PROs) are measures of patients' health that are conveyed directly by individual patients. These measures serve as instruments to evaluate the impact of interventions on any aspect of patients' health, from specific symptoms to broader quality-of-life indicators. However, their effectiveness relies on capturing relevant factors accurately. While commonly utilized in clinical trials, PROs extend their influence across healthcare settings, informing clinicians, healthcare payers, regulators, and administrators to guide quality improvement and reimbursement decisions. Neglecting health equity considerations in PRO development and implementation widens health disparities, leading to biased interpretations, medical mismanagement, and poor health outcomes among minoritized groups. To foster equitable healthcare, efforts must focus on considering the values of underrepresented populations in PRO design, addressing barriers to completion, enhancing representation in research, providing cultural competency training for clinicians, and allocating research funding to support health equity research. By addressing these issues, advances can be made towards fostering inclusive, equitable healthcare for all individuals.

Perceived Barriers Toward Patient-Reported Outcome Implementation in Cancer Care: An International Scoping Survey.

Implementation of patient-reported outcomes (PROs) collection is an important priority in cancer care. We examined perceived barriers toward implementing PRO collection between centers with and without PRO infrastructure and administrators and nonadministrators. We performed a multinational survey of oncology practitioners on their perceived barriers to PRO implementations. Multivariable regression models evaluated for differences in perceived barriers to PRO implementation between groups, adjusted for demographic and institutional variables. Among 358 oncology practitioners representing six geographic regions, 31% worked at centers that did not have PRO infrastructure and 26% self-reported as administrators. Administrators were more likely to perceive concerns with liability issues (aOR, 2.00 [95% CI, 1.12 to 3.57]; P = .02) while having nonsignificant trend toward less likely perceiving concerns with disruption of workflow (aOR, 0.58 [95% CI, 0.32 to 1.03]; P = .06) and nonadherence of PRO reporting (aOR, 0.53 [95% CI, 0.26 to 1.08]; P = .08) as barriers. Respondents from centers without PRO infrastructure were more likely to perceive that not having access to a local PRO expert (aOR, 6.59 [95% CI, 3.81 to 11.42]; P < .001), being unsure how to apply PROs in clinical decisions (aOR, 4.20 [95% CI, 2.32 to 7.63]; P < .001), and being unsure about selecting PRO measures (aOR, 3.36 [95% CI, 2.00 to 5.66]; P < .001) as barriers. Heat map analyses identified the largest differences between participants from centers with and without PRO infrastructure in agreed-upon barriers were (1) not having a local PRO expert, (2) being unsure about selecting PRO measures, and (3) not recognizing the role of PROs at the institutional level. Perceived barriers toward PRO implementation differ between administrators and nonadministrators and practitioners at centers with and without PRO infrastructure. PRO implementation teams should consider as part of a comprehensive strategy including frontline clinicians and administrators and members with PRO experience within teams.

SYSTEMATIC REVIEW OF USE OF PATIENT REPORTED OUTCOME IN INTERVENTIONAL RADIOLOGY

Introduction: At present, the implementation of patient-reported outcomes in interventional radiology is not widespread. However, they are capable of significantly impacting the manner in which we deliver healthcare. Patient-reported outcomes provide an avenue for evaluating the perceived advantages that patients encounter subsequent to a medical procedure. Furthermore, they facilitate a comparison of these results with those of open procedures that are more invasive, as perceived by the patient. The aim: This study review of use of patient reported outcome in interventional radiology. Methods: For this systematic review, publications that were published from 2012 to 2023 were taken into account during the search process. This was achieved through the utilization of numerous online reference sources, such as Pubmed and SagePub. The decision was made to exclude review articles, previously published works, and incomplete works. Result: We obtained 94 articles from Pubmed and 110 from SagePub. The therapies we extracted were 1 article from Pubmed and 3 articles from SagePub. Conclusion: Quality of life and patient perception must be respected as one of the parameters of successful therapy. Previous research shows that PRO can be used with good validity and reliability as a therapeutic outcome parameter in many cases, including interventional radiology.

Exploring, describing, and mapping the constitutive elements of patient-reported outcomes (PROs) used in clinical practice

Abstract&#x0D; Background: The functionality and purpose of patient-reported outcomes (PROs) have evolved as a result of their digitalisation and extended application in clinical practice. The diffusion of PROs on various organisational levels in different sectors and disease areas has further shaped their usage and construction. Thus, this paper identifies the main elements constituting a PRO in the context of clinical practice. The aim is to create a concept map (PRO Elements) grounded in the extant literature, translating, combining, and mediating different interpretations of PRO among stakeholders, to enhance users’ understanding and use of PROs with a particular focus on patient participation.&#x0D; Methods: The study is based on a systematic document analysis—a sub-study of an extensive scoping review (PubMed, Embase, CINAHL, Scopus) of PROs and patient participation in clinical practice.&#x0D; Results: The mapping of PRO reveals that, in clinical practice, a combination of eight main elements constitutes a PRO— validated questionnaire(s), developers, content, measures, mediation, respondents, data, and outcomes – forming the concept map called PRO Elements.&#x0D; Conclusion: The article provides an interdisciplinary mapping, presentation, and discussion of PROs’ constitutive elements, with an emphasis on patient participation. The holistic conceptualisation map illustrates various types of PROs that may prompt stakeholders to engage in discourse on the development, implementation, and evaluation of PROs to create more coherent and beneficial applications.

A Swiss digital Delphi study on patient-reported outcomes.

Health-related quality of life (HRQoL) indicators are patient-reported outcomes (PROs). PROs are defined as any report of the status of a patient's health condition or health behaviour that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. Despite Swiss national bodies (FOPH, FMH) recognising the potential of PRO measures (PROMs) for improving the health system, no consensus has yet emerged regarding a generic PROM framework or specific domains for practical uptake. The aim of the present digital Delphi study was to generate a consensual Swiss expert opinion on a generic PROM framework, measurement domains and items from a validated instrument (PROMIS [Patient-Reported Outcome Measurement Information System]) as well as on the role and implementation of PROs in the Swiss healthcare system via PRO consensus statements. A 4-round digital Delphi study was conducted among Swiss PRO stakeholders. A total of n = 21 Swiss PROM stakeholders completed round 1 surveys on the PROM framework. During the stakeholder meeting, n = 11 stakeholders completed round 2 and round 3 surveys pertaining to measurement domains and items, respectively. In-meeting key questions and discussion items were extracted, consolidated into statements and subjected to consensus voting in a round 4, post-meeting survey. Consensus was defined as ≥70% agreement. Pre-meeting, agreement was reached for the tripartite framework of physical, mental and social health (95-100%). During the meeting, agreement was reached on all seven measurement domains of a generic PROM (PROMIS-29), ranging from 80% (Anxiety, Sleep Disturbance) to 100% (Pain Interference, Depression, Ability to Participate in Social Roles). Consensus was also reached for all PROMIS-29 items, with average domain consensus ranging from 83% (Sleep Disturbance, Ability to Participate in Social Roles) to 100% (Depression). Finally, four post-meeting consensus statements regarding PROs in Switzerland reached agreement. A Delphi method can help identify areas of need regarding PROMs in Switzerland. The current study identified a generic PROM as a missing quality indicator for the Swiss national health system's value. A pre-meeting informational briefing, expert presentations and moderation supported three voting rounds to help identify PROMIS-29 as a PROM framework (round 1), measurement domains (round 2) and items (round 3) as a basis for further validation research. The empirical agreement among diverse stakeholders supports broad consensus towards preliminary feasibility of integrating generic PROMs into the Swiss health system based on content relevance.

Harmonization of patient-reported outcome measurement across four academic medical centers: Multi-site clinician focus group results from the Carolinas Collaborative Initiative.

336 Background: Use of patient-reported outcomes (PROs) to monitor symptoms in cancer care demonstrates clinical benefit, but implementation of PROs across healthcare settings remains low. We conducted focus groups (FGs) with stakeholders from four academic medical centers (AMCs) to identify perceived barriers and facilitators to implementing PROs in routine care. Methods: Stakeholders were recruited to participate in FGs and asked to identify barriers and facilitators of future PRO implementation in their respective healthcare setting. Transcripts were coded and synthesized via thematic content analysis. Results: Seventy stakeholders participated in one of 14 FGs (leadership groups, n = 5; nurse groups, n = 4; physician groups, n = 5) stratified by role and site. The mean FG size was 5 (range = 2 to 14). Three overarching domains were identified: Workflow, Training and Implementation, and Data-Driven Action. Table 1 shows the relative frequency of notable codes associated with each domain across FGs aggregated by stakeholder role. Themes within each domain are: Workflow: current workflow dynamics inhibit PRO implementation (code = Workflow, Table 1); more resources are necessary to adjust clinical workflow and the EMR to facilitate administration and clinicians’ ability to respond to concerning symptoms (code = Resources needed, Table 1). Training and Implementation: clinicians may be unaware of the utility of PROs; training about the clinical relevance of PROs may help facilitate integration (code = Training needs, Table 1). Data-Driven Action: data derived from PROs must be interpretable and actionable to promote sustained utility (code = How to display PROs, Table 1). Tailored measures for specific clinical populations are needed, along with information on clinically significant scores, meaningful change thresholds, predictive value, and whether integration of PROs improves healthcare quality. Conclusions: Similar barriers to PRO implementation were identified across four AMCs. Infrastructure is needed in each AMC to help clinics integrate PROs. Resources to address workflow inefficiencies, EMR integration, clinician training, and follow-up support may help facilitate integration. Academic medical centers must also ensure that data derived from PROs are relevant and actionable.[Table: see text]

Patient engagement with a portal-based symptom management program across six health systems.

351 Background: Collecting patient-reported outcomes (PROs) improves quality of life and self-efficacy, reduces acute care needs, and extends survival for cancer patients. Prior studies evaluating the efficacy of PROs have often relied on unrepresentative populations seen at well-resourced health systems and treated in controlled settings. As a result, widespread PRO implementation has not been achieved. We sought to study the reach of an electronic PRO-based, EHR-integrated symptom management system (eSyM) that was deployed in routine clinical practice across six diverse health systems. Methods: All patients receiving medical oncology (MO) or surgical (SURG) care for a confirmed or suspected gastrointestinal, gynecologic, or thoracic malignancy were invited to use eSyM – a patient portal-based tool that asks patients to respond to symptom questionnaires, provides symptom management resources, and fosters patient-clinician communication. Study outcomes included any portal use, sending a message via the portal, and completing an eSyM symptom questionnaire via the portal. Spearman coefficients were used to assess the correlation between portal message use and eSyM questionnaire completion. Multivariable logistic regression models were used to identify factors associated with completing at least one eSyM questionnaire. Results: From September 2019 to March 2023, 9589 MO and 13,297 SURG patients had access to eSyM. Patient characteristics and usage rates were analyzed [Table]. Among portal users, most patients accessed it via the web app only, with 39.2% of MO and 42.6% of SURG patients accessing it via both the web and mobile apps. Correlations between message use and questionnaire use were moderate (0.48 for MO, 0.43 for SURG). Notably, 17.9% of MO and 21.7% of SURG patients sent a portal message but did not submit an eSyM questionnaire. Factors associated with lower odds of eSyM questionnaire completion for both the MO and SURG cohorts included: older age, male sex, Black race, Medicaid insurance, and being single, widowed, or disabled. Conclusions: In a diverse patient population from six community-based cancer centers, over 80% used the portal for any reason, over 58% sent a message, and over 46% submitted at least one eSyM questionnaire. Strategies that improve patient engagement and ameliorate disparities with ePRO-based programs are needed. Some eSyM non-responders never used the portal, whereas others used the portal for different reasons, suggesting that technical and non-technical barriers to ePRO programs exist.[Table: see text]

Paving the way for patient centricity in real-world evidence (RWE): Qualitative interviews to identify considerations for wider implementation of patient-reported outcomes in RWE generation

ObjectivesReal-world evidence (RWE) generation can be enhanced by including patient-reported outcomes (PROs). Methods for collecting and using PRO data in the real-world setting are currently underdeveloped and there is no international guidance specific to its use in this context. This study explored stakeholders' perspectives and needs for using PROs in RWE generation. Barriers, facilitators, and opportunities for wider use of PROs in real-world studies were also investigated. MethodsOnline semi-structured interviews were conducted with international stakeholders: patients, patient advocates, regulators, payers, clinicians, academic researchers, and industry experts. Interviews were recorded, transcribed verbatim and analysed using NVivo 20. Thematic analysis was conducted based on the updated Consolidated Framework for Implementation Research (CFIR). ResultsTwenty-three interviews were conducted. Participants confirmed that the use of PROs in RWE generation is not yet well established. Participants expressed a mixed level of confidence in the value of PROs collected in a real-world setting. Operational challenges associated with collecting routine PRO data to inform care delivery at the individual level (e.g., setting up infrastructure) need to be addressed. Methodological and other challenges (e.g., financing research) associated with collecting prospective de novo data in a real-world setting should be considered to facilitate PRO utilisation in real-world studies. ConclusionsSeveral opportunities and challenges were identified regarding the broader use of PROs in RWE research. Joint efforts from different stakeholders are needed to maximise PRO implementation, with consideration given to each stakeholders’ specific needs (e.g., by developing good practices).

Integration of the CLEFT-Q Patient-Reported Outcome Tool into a Multidisciplinary Cleft and Craniofacial Clinic: A Proof of Concept.

Implementation of patient-reported outcome (PRO) tools has increased internationally in a variety of clinical settings, with emerging evidence suggesting benefits for patient satisfaction, improved patient-provider communication, and management of chronic conditions. However, integrating PROs into clinical workflow remains a barrier to implementation, with common challenges including patient completion, provider review of results, and future accessibility of data. Cleft lip and/or palate presents with a variety of aesthetic, functional, and psychosocial sequelae optimally managed by a multidisciplinary team, and the CLEFT-Q is a validated 12-module PRO that captures patient perception in these domains. Given the emerging proven benefits of using PROs in a clinical setting, the authors integrated the CLEFT-Q PRO at a multidisciplinary cleft and craniofacial clinic at a large, urban, tertiary care center. The authors collaborated with their institution's electronic health record clinical informatics team to automatically identify eligible cleft lip and/or palate patients and generate the CLEFT-Q PRO before weekly multidisciplinary cleft and craniofacial clinic days. Patient results were automatically scored, compared with age-based normative data, and populated into the electronic health record patient note. CLEFT-Q results were viewed by clinicians during patient visits to initiate module-specific discussion in relation to patient age-based normative results. Patient-specific CLEFT-Q data were also discussed during multidisciplinary cleft and craniofacial team discussions to aid in clinical decision-making. This experience may have applicability to other PRO tools in plastic surgery and other medical specialties where integrating PROs may yield superior patient experience and outcomes.

693-P: Diabetes Distress Is Common in Newly Diagnosed Families in the 4T Study and Families Are Receptive to Psychological Services

Psychosocial states significantly impact T1D care and management for youth and their families. As part of a clinical pragmatic study, we report the number of elevated Patient Reported Outcomes (PROs) in newly diagnosed families and track their progress to psychological care. Parents/guardians (PG, n=125/133 4T Study 1 participants) and youth ≥11 years (n=60) were eligible to complete baseline, 3-, and 6-month PROs. PG completed Diabetes Distress Scale - Parent (DDS-P) and youth completed Diabetes Distress Scale (DDS-2) and PROMIS Pediatric Global Health Scale (PGH). Elevated PROs were based on published guidelines and were referred to the clinic's psychological services. Survey completeness was verified by staff to identify false flags. Staff reapproached the participant's psychologist for re-flagged PROs &amp;gt;3 months after the last visit. Over the three study time periods, a total of 99 PROs flags were evaluated (Table). At baseline, there were 32% flagged PROs, which decreased to 27% and 23% at 3 and 6 months, respectively. Elevated DDS-P was the most common reason for referral (75%). Early psychological intervention may explain the reduction in elevated PROs over the study period. With the implementation of systematic PROs in this new onset population, we observed it was common to have diabetes distress and families were receptive to psychological services. Disclosure A.Schneider-utaka: None. F.K.Bishop: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. P.Prahalad: None. M.Desai: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. K.K.Hood: Consultant; Cecelia Health. A.Addala: None. E.Pang: None. A.L.Cortes-navarro: None. I.Balistreri: None. A.Loyola: None. N.Arrizon-ruiz: None. S.A.Alamarie: None. V.Ritter: None. B.Shaw: None. Funding National Institutes of Health (R18DK122422)

PRO-Act: a healthcare provider workshop outlining the added value of implementing PROs in routine HIV practice

Patient Reported Outcomes (PROs) are an evidenced way of adding value to routine clinical care. As a source of unique information on the effect of a medical condition and its treatment from the patients’ perspective (Mercieca-Bebber et al. in Patient Relat Outcome Meas 9: 353–367, https://doi.org/10.2147/PROM.S156279, 2018), PROs allow for an improved assessment in routine clinical care of symptoms, side effects, functional outcomes (physical, sexual, social, emotional, cognitive functioning), and health-related quality of life (HRQoL). By helping to align healthcare providers’ interventions with what matters most to the patient, PROs contribute to the individualized choice of Anti-Retroviral Therapy (Carfora et al. in PLoS ONE 17(4): e0267030, https://doi.org/10.1371/journal.pone.0267030, 2022) as a paramount component of tailored and person-centred care management, in routine clinical practice. This article outlines a practical framework and process tested in Portugal to raise awareness of PROs’ added value, and to help guide first steps in the implementation and seamless integration of PROs, in routine HIV care.

Evaluating the Implementation of Patient-Reported Outcomes in Heart Failure Clinic: A Qualitative Assessment.

Patient-reported outcomes (PROs) may improve care for patients with heart failure. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a patient survey that captures symptom frequency, symptom burden, physical limitations, social limitations, and quality of life. Despite the utility of PROs and the KCCQ-12, the implementation and routine use of these measures can be difficult. We conducted an evaluation of clinician perceptions of the KCCQ-12 to identify barriers and facilitators to implementation into clinical practice. We conducted interviews with cardiologists from 4 institutions across the United States and Canada (n=16) and observed clinic visits at 1 institution in Northern California (n=5). Qualitative analysis was conducted in 2 rounds: (1) rapid analysis constructed around major themes related to the aims of the study and (2) content analysis with codes derived from the rapid analysis and implementation science. Most heart failure physicians and advanced practice clinicians reported that the KCCQ-12 was acceptable, appropriate, and useful in clinical care. Clinician engagement efforts, trialability, and the straightforward design of the KCCQ-12 facilitated its use in clinical care. Further opportunities identified to facilitate implementation include more streamlined integration into the electronic health record and comprehensive staff education on PROs. Participants highlighted that the KCCQ-12 was useful in clinic visits to improve the consistency of patient history taking, focus patient-clinician conversations, collect a more accurate account of patient quality of life, track trends in patient well-being over time, and refine clinical decision-making. In this qualitative study, clinicians reported that the KCCQ-12 enhanced several aspects of heart failure patient care. Use of the KCCQ-12 was facilitated by a robust clinician engagement campaign and the design of the KCCQ-12 itself. Future implementation of PROs in heart failure clinic should focus on streamlining electronic health record integration and providing additional staff education on the value of PROs. URL: https://clinicaltrials.gov; Unique identifier: NCT04164004.

Valbenazine Decreases Disease Burden in Patients with Chorea Associated with Huntington Disease: Patient-Reported Huntington Disease Health Index (HD-HI) Results From the KINECT-HD Trial (P2-11.012)

Valbenazine Decreases Disease Burden in Patients with Chorea Associated with Huntington Disease: Patient-Reported Huntington Disease Health Index (HD-HI) Results From the KINECT-HD Trial (P2-11.012)

CO171 Use of Patient-Reported Outcomes (PROs) and Its Implementation in Clinical Care in India: A Clinician's Perspective

The objective of this questionnaire-based survey is to assess the usage of the patient-reported outcomes (PROs) in routine clinical care in India and determine the impact of PRO implementation in outpatient management.

Athletic Trainers’ Perceptions of Patient-Reported Outcomes After Completing a Clinic-Wide Implementation Program

Patient-reported outcomes (PROs) are important for capturing patients’ perspectives on quality of life and aiding in provision of whole-person patient care; yet, PROs are not routinely used in athletic training practice. We investigated the athletic trainers’ perceptions of using PROs after they had completed a required PRO implementation program. Athletic trainers had positive perceptions after integrating PROs into clinical practice. Barriers associated with PRO use may be improved with a support structure that requires accountability and provides resources such as reminders and professional development to recognize ways that PROs can be used to improve patient care.

Patient-reported outcomes in a linguistically diverse cancer population: Addressing barriers to access.

168 Background: The census metropolitan area served by BC Cancer is Vancouver which has a population of 2.4 million. Census Canada noted the mother tongue learned in childhood and still spoken was: 54% English, 17% Indo-European, 16% Chinese, 10% Indo-Iranian, 3% English+other language, 2% other. At BC Cancer, implementation of patient reported outcomes (PROs) was launched 1 year ago with consideration of preferred language. Our goal was to examine the implementation of PROs with respect to equity of access and language preferences. Methods: BC Cancer Vancouver implemented PROs including the Edmonton Symptom Assessment Scale Revised, Canadian Problem Checklist and EQ5D in April 2021 using a web-based platform. A 1-year cohort was reviewed for patients’ mother tongue and the language used for the PROs. Qualitative interviews were undertaken for non-English mother tongue patients to ask for preferred language of PROs and reasons for the choice if mother tongue was not selected. Results: 86 patients were enrolled in the PRO program. Baseline characteristics: 66% female, age 30% &lt; 60/ 31% 60-69/ 39% &gt;70, primary site 54% lung/ 34% colorectal/ 18% other. Ethnic origin: 53% North American and European, 40% East and Southeast Asian, 2% Latin/Central and South American, 3% South Asian, 1% Indigenous, 1% other. Mother tongue: 52% English, 48% non-English (39% English proficient, 9% low English proficiency). Patient preferred language for PROs: 81% English, 11% Chinese, 7% other. Reasons for non-English mother tongue preference for English language included comfort with written English, use of family assistance completing questionnaires for both language and familiarity with electronic devices. Conclusions: In the Vancouver linguistically diverse cancer population, the majority of patients preferred English language PROs. Reasons for this include proficiency in the written language and the use of family members to complete the questionnaires. With 39% of patients over the age of 70 in our study, the use of electronic devices for completion may have introduced an additional barrier to access. In clinic iPad questionnaires with nursing and care aide support have been introduced to help address this gap. Clinical trial information: NCT05057234.

Implementation of thyroid-related patient-reported outcomes in routine clinical practice.

Patient-reported outcomes (PROs) are increasingly used in clinical practice to improve clinical care. Multiple studies show that systematic use of PROs can enhance communication with patients and improve patient satisfaction, symptom management and quality of life. Further, such data can be aggregated to examine health levels for patient groups, improve quality of care, and compare patient outcomes at the institutional, regional or national level. However, there are barriers and challenges that should be handled appropriately to achieve successful implementation of PROs in routine clinical practice. This paper briefly overviews thyroid-related PROs, describes unsolved quality of life issues in benign thyroid diseases, provides examples of routine collection of PROs, and summarizes key points facilitating successful implementation of thyroid-related PROs in routine clinical practice. Finally, the paper touches upon future directions of PRO research.

A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020.

IntroductionCancer and corresponding available treatments are associated with substantial symptoms and functional limitations. In this context, collection of patient-reported outcomes (PRO) in clinical trials gained special interest and is recommended by regulatory authorities. Within clinical trials framework, PRO may provide evidence to support medicines approval, labeling and marketing claims. This study aims to analyze the existing evidence based on PRO as part of new oncology indications receiving positive opinions issued by the European Medicines Agency (EMA) between 2017 and 2020 and to identify PRO related label claims granted.MethodologyOncology medicinal products and indications approved by the European Commission following a positive opinion from the EMA between 2017 and 2020 were identified. European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC) were reviewed for each medicinal product to identify use of PRO and PRO label claims.ResultsA total of 128 oncology indications, corresponding to 76 medicines, were approved; of those, 100 (78.1%) included PRO in the confirmatory clinical trials. Thirty-seven indications were supported by double-blind randomized trials and the remainder 63 by open-label trials. Out of the 104 confirmatory trials analyzed, PRO were defined as a secondary endpoint in 60 studies (57.7%), exploratory in 31 (29.8%) and as both in 13 (12.5%). In total, 54 different PRO measures (PROM) were used, of those 41 (75.9%) were disease-specific measures. Nevertheless, PROM selected relied on the EORTC (41.3%), FACIT (17.1%) and EQ-5D (29.2%) measures. A total of 76 indications (59.4%) had PRO reviewers comments included in the EPAR, however only 22 indications (17.8%) included label claims in the SmPC. The reasons identified in the EMA assessment supporting the exclusion of PRO claims were described for 34 indications (44.7%).ConclusionsDespite growing recognition of the value of PRO data for the development of improved cancer therapies, PRO implementation remains challenging. The main reasons identified in our study are related with study design, missing data, study conduct and PROM selection.

An implementation study of electronic assessment of patient-reported outcomes in inpatient radiation oncology

PurposeDespite evidence for clinical benefits, recommendations in guidelines, and options for electronic data collection, routine assessment of patient-reported outcomes (PROs) is mostly not implemented in clinical practice. This study aimed to plan, conduct and evaluate the implementation of electronic PRO (e-PRO) assessment in the clinical routine of an inpatient radiation oncology clinic.MethodsThe guideline- and evidence-based, stepwise approach of this single-center implementation study comprised preparatory analyses of current practice, selection of assessment instruments and times, development of staff training, and evidence-based recommendations regarding the use of the e-PRO assessment, as well as on-site support of the implementation. Process evaluation focused on potential clinical benefit (number of documented symptoms and supportive measures), feasibility and acceptance (patient contacts resulting in completion/non-completion of the e-PRO assessment, reasons for non-completion, preconditions, facilitators and barriers of implementation), and required resources (duration of patient contacts to explain/support the completion).ResultsSelection of instruments and assessment times resulted in initial assessment at admission (EORTC QLQ-C30, QSR 10), daily symptom monitoring (EORTC single items), and assessment at discharge (EORTC QLQ-C30). Recommendations for PRO-based clinical action and self-management advice for patients concerning nine core symptoms were developed. Staff training comprised group and face-to-face meetings and an additional e-learning course was developed. Analyses of clinical records showed that e-PRO assessment identified more symptoms followed by a higher number of supportive measures compared to records of patients without e-PRO assessment. Analysis of n = 1597 patient contacts resulted in n = 1355 (84.9%) completed e-PROs (initial assessment: n = 355, monitoring: n = 967, final assessment: n = 44) and n = 242 (15.2%) non-completions. Instructions or support to complete e-PROs took on average 5.5 ± 5.3 min per patient contact. The most challenging issue was the integration of the results in clinical practice.ConclusionE-PRO assessment in oncologic inpatient settings is acceptable for patients and can support symptom identification and the initiation of supportive measures. The challenge of making the “data actionable” within the clinical workflow and motivating clinical staff to use the results became evident.