Implementation Of Patient-reported Outcomes Research Articles

Patient Reported Outcomes in Metastatic Breast Cancer Studies: Evaluating the Impact of the FDA Guidance for Industry

Introduction: Over the last two decades, a number of new therapies have demonstrated improved overall survival in metastatic breast cancer (MBC) [10]. Despite these advances, MBC remains incurable with a median survival of less than three years [7, 10, 11, 15]. Prolonging survival and maintaining quality of life (QoL) continue to be the central goals of therapy. Unlike the early stages of breast cancer, the management of MBC is less clearly defined, with no specific treatment recognized as the standard of care [15]. Several studies have sought to determine an optimal regimen for the management of MBC with aims to prolong survival, however relatively few adequately powered studies have directly addressed QoL [8]. Patient reported outcomes (PROs) are instruments used to elicit the patient experience thereby gaining insight into a particular health state and aiding in the assessment of QoL [5]. As the prevalence of PROs grew, the FDA released in December 2009 an industry guidance on the implementation of PROs in clinical trials for the development of medical products and to support labeling claims [1]. This study was undertaken with aims to evaluate the impact of the FDA guidance on the use of PROs as standard endpoints in randomized phase two or three clinical trials assessing therapeutic options in MBC. Methods: Clinicaltrials.gov’s advanced search tool was used to capture registered interventional phase two or three clinical trials in adult patients with MBC conducted in the United States that began recruitment between January 1, 2002 and December 31, 2017. Trials with QoL or PROs listed as primary or secondary endpoints on Clinicaltrials.gov were subsequently identified. Segmented regression analysis of the interrupted time series data [18] was used to estimate dynamic changes pre and post adoption of the FDA guidance. Results: A total of 677 studies were identified, 72 of which used PROs. Prior to adoption of the FDA guidance, there is a nonsignificant trend towards increasing PRO use at a rate of 0.4% per year (p > 0.05). At the time of adoption, there is a one-time nonsignificant increase of 0.6% in PRO use (p > 0.05). After adoption, there is a nonsignificant trend towards decreasing PRO use at a rate of 0.3% per year (p > 0.05). Discussion: Our study results demonstrated that despite the FDA guidance, there has been little change in the use of PROs as endpoints in MBC studies. This missed opportunity to elicit the patient experience inherently limits evidence often used to counsel patients and support their decision-making framework as they focus on their priorities in selecting treatment options.

AMCP Partnership Forum: Building the Foundation for Patient-Reported Outcomes-Infrastructure and Methodologies.

Section 3002 of the 21st Century Cures Act, which was signed into law in December 2016, requires the FDA to develop one or more sets of new guidances regarding the collection of patient experience data. To explore how patient-reported outcomes (PROs) can support value-based care and discuss challenges to using PROs more widely, the Academy of Managed Care Pharmacy (AMCP) convened a stakeholder forum in 2017 on PROs and the role they can play in defining the value of health care interventions. This forum achieved consensus on the importance of PROs in improving patient care through implementing value-based payment models and the need for strong organizational systems to fully adopt and use PROs in health care decision making. To explore strategies to build on these findings and implement them in practice, AMCP convened a second forum on October 25, 2018, in Orlando, FL, to focus on identifying specific methods and infrastructure to support the ideal use of PROs in practice. In light of the FDA's plans to propose new guidance for incorporating PROs in the regulatory process, this forum focused on the following: (a) describing the current state of using PROs for FDA regulatory and value-based coverage decisions; (b) defining a process for collecting and sharing PROs with the FDA and managed care organizations for value-based decisions; (c) identifying the necessary infrastructure needed to support the ideal use of PROs; and (d) identifying the health information technology strategies needed to support PRO use across managed care stakeholders. Strategies for the development and implementation of PROs were discussed throughout the forum, including a focus on appropriate activities to address the needs of patients, health care providers, managed care organizations, and life science companies and researchers. Health care leaders representing health plans, integrated delivery systems, pharmacy benefit managers, employers, national associations of health care professionals, patient advocacy organizations, health infrastructure technology companies and biopharmaceutical companies participated in the forum. The AMCP forum was supported in collaboration with Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, PhRMA, Sanofi, Takeda, and Xcenda. DISCLOSURES: The AMCP Partnership Forum and the development of the proceedings document were supported by Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, PhRMA, Sanofi, Takeda, and Xcenda.

Patient-reported outcomes in lung and esophageal cancer.

Carcinomas of the lung and esophagus are associated with significant disease and treatment related morbidity. Measuring patients' self-perceived notion of their health-related quality of life (HRQOL), throughout the course of illness, is central to the delivery of comprehensive, patient-centered care. This article reviews commonly used HRQOL instruments in thoracic surgery and discusses the integral role of patient-reported outcomes (PROs) in comparative effectiveness research and prognostication in the realm of lung and esophageal cancer. We also highlight challenges and future directions for widespread implementation of PROs into clinical and research practice.

Provider perspectives on the integration of patient-reported outcomes in an electronic health record.

ObjectiveIntegrating patient-reported outcomes (PROs) into electronic health records (EHRs) can improve patient-provider communication and delivery of care. However, new system implementation in health-care institutions is often accompanied by a change in clinical workflow and organizational culture. This study examines how well an EHR-integrated PRO system fits clinical workflows and individual needs of different provider groups within 2 clinics.Materials and MethodsNorthwestern Medicine developed and implemented an EHR-integrated PRO system within the orthopedics and oncology departments. We conducted interviews with 11 providers who had interacted with the system. Through thematic analysis, we synthesized themes regarding provider perspectives on clinical workflow, individual needs, and system features.ResultsOur findings show that EHR-integrated PROs facilitate targeted conversation with patients and automated triage for psychosocial care. However, physicians, psychosocial providers, and medical assistants faced different challenges in their use of the PRO system. Barriers mainly stemmed from a lack of actionable data, workflow disruption, technical issues, and a lack of incentives.DiscussionThis study sheds light on the ecosystem around EHR-integrated PRO systems (such as user needs and organizational factors). We present recommendations to address challenges facing PRO implementation, such as optimizing data collection and auto-referral processes, improving data visualizations, designing effective educational materials, and prioritizing the primary user group.ConclusionPRO integration into routine care can be beneficial but also require effective technology design and workflow configuration to reach full potential use. This study provides insights into how patient-generated health data can be better integrated into clinical practice and care delivery processes.

Advancing the use of patient-reported outcomes in practice: understanding challenges, opportunities, and the potential of health information technology.

The effective use of patient-reported outcomes (PROs) can play a critical role in improving health care delivery and patient experience with care. However, PROs are not widely collected and used in clinical practice. This study aims to understand current opportunities and challenges with the use of PROs and the potential for health information technology (IT) to advance their use. The Agency for Healthcare Research and Quality held two technical expert panel (TEP) meetings to discuss the current use of PROs, challenges, and opportunities in implementation, and how health IT can be leveraged to support effective PRO use in clinical practice. Results were synthesized to identify major themes and takeaways based on different stages of PRO data utilization. Findings from the TEP meetings indicated varying degrees of PRO usage in ambulatory care settings. Practices often lack a business case to collect PROs. Primary care physicians face more challenges than specialists in selecting appropriate PRO measures due to extensive variation in their patient populations. Providers also need training to use PRO data for shared decision making and population health management. Potential research areas to address PRO implementation challenges include measures harmonization, implementation process and workflow, electronic data collection and integration, and user-friendly data displays. Opportunities exist during different stages of PRO implementation to advance the use of PROs in clinical practice. Health IT can be utilized to address challenges in data collection, integration, and visualization to make PRO data accessible and understandable to patients and providers.

Successes with and barriers to patient-reported outcome deployment at a comprehensive cancer center.

292 Background: Routine collection of patient reported outcomes (PROs) reduces hospitalizations and improves quality of life. In the absence of clear implementation guidelines and research guiding deployment, PROs may not have the desired impact on outcomes in routine oncology practice. We share lessons learned from PRO deployment at Dana-Farber Cancer Institute. Methods: We developed a symptom/toxicity assessment tool based on the PRO-CTCAE to capture 15 symptomatic adverse events with a 1-week recall: fatigue/ decreased appetite/insomnia/ shortness of breath/numbness and tingling/concentration, general pain/anxiety/sadness, rash, nausea/vomiting/fever, constipation, and diarrhea. Responses from eligible English-literate patients scheduled for a gastrointestinal cancer center or adult palliative care visit between January 18 to March 22, 2018 were transmitted directly from clinic tablet to the EMR. To evaluate the deployment, we sought qualitative feedback from clinic staff and three multidisciplinary working groups comprised of patients, nurses, pharmacists, operations leaders, quality/safety experts, and health services researchers to identify technical and workflow gaps in PRO Content, Implementation, and Analytics. Results: We noted a 38% response rate of the N = 4440 PROs assigned to N = 4440 scheduled visits for N = 2055 unique patients (36% were completed, 2% started but not completed); 62% were not started. Workflow enhancement requests include an updated summary view, a clinical documentation tool, a scoring algorithm to highlight severe responses, and a quality metric dashboard to evaluate the deployment. Ongoing analyses are studying the proportion of moderate-severe symptomatic adverse events reported and their association with provider action (i.e., supportive care referral, chemotherapy treatment plan modification, or unplanned ED/hospitalization in the subsequent 30 days). Conclusions: Refinement of the PRO deployment strategy is needed to guide implementation efforts and demonstrate meaningful impact in routine oncology practice.

Patient-Reported Outcomes for Breast Cancer.

Patient-reported outcomes (PROs) provide insight into how patients perceive health and treatment effects, how treatments impact outcomes, and are helpful in determining how disease and surgical interventions impact many aspects of a patients' life. Commonly utilized metrics include survival and disease control, degree of recovery and functional status, access to treatment, treatment-related complications, health-related quality of life, and long-term consequences of therapy. The key to value-based, patient-centered health care is systematically incorporating patient input into the measures that they consider to be the most important outcomes for a particular medical condition while minimizing costs of care. This manuscript reviews the development and validation of multiple available PROs in breast surgical oncology and reconstruction, their impact in improving patient-physician communication and treatment outcome, and potential for impacting reimbursement. The implementation of PROs can be complex and challenging and care must be taken to minimize the potential for survey fatigue by patients and the potential financial burden for implementation, maintenance, and analyses of collected data. Because there is an increased emphasis in providing high-value care for cancer patients, the widespread incorporation of transparent breast-specific PROs stratified by treatments received and disease stage will be essential in delivering exceptional quality care.

Systemwide Implementation of Patient-Reported Outcomes in Routine Clinical Care at a Children's Hospital

BackgroundDespite a growing literature on patient-reported outcomes (PROs), little has been written to guide development of a standardized, systemwide PRO program across multiple clinics and conditions. A PRO implementation program, which was created at Cincinnati Children's Hospital Medical Center, a large children's hospital, can serve as a standardized approach for the use of PROs in a clinical setting. MethodsRecommended standardized PRO implementation components include identification of a committed clinical leader and team, selection of an instrument that addresses the identified outcome of interest, specifying threshold scores that indicate when an intervention is needed, identification of clinical interventions to be triggered by threshold scores, provision of training for providers and staff involved in the PRO implementation process, and the measurement and monitoring of PRO use. ResultsFor each instrument, the completion goal is 80%, defined as the number of PRO measures that were actually completed divided by the number that should have been completed. The overall combined completion rate is 75% for the 68 unique instruments currently in use. Case studies of specific clinical team experiences demonstrate the value of using PROs and the implementation components and shows how PROs are used to promote patient-centered care. ConclusionData on PRO implementation are collected on an ongoing basis to confirm the value of the program, define ongoing improvement, and fuel collaborative research to further refine essential implementation components and successful spread. Next steps include measuring the influence of PRO use on coproduction of patient-centered clinical care and the impact PRO measurement has on patient outcomes.

Implementation of Patient-Reported Outcomes in Routine Medical Care.

There is increasing interest to integrate collection of patient-reported outcomes (PROs) in routine practice to enhance clinical care. Multiple studies show that systematic monitoring of patients using PROs improves patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. The general approach includes a brief electronic survey, administered via the Web or an app or an automated telephone system, with alerts to clinicians for concerning or worsening issues. Patients have generally been asked to self-report on a regular basis (remotely between visits and/or at visits), with reminders prompting patients to self-report that are sent via email, text, or automated phone message. More recently, care management pathways for patients and clinicians have been triggered by PRO system alerts. PRO systems may be free-standing, integrated into electronic health record systems or patient portals, or native functionality of an electronic health record. Despite potential benefits, there are challenges with integrating PROs into practice for monitoring patient status, as there are with any modifications to existing clinical processes. These challenges range from administrative to technical to workflow. A session at the 2018 ASCO Annual Meeting was dedicated to the implementation of PROs in clinical practice. The session focused on practical examples of PRO implementations, with honest reflections on barriers and strategies that may be generalizable to other systems looking to implement PROs. Panelists for that session are the authors of this paper, which describes their respective experiences implementing PROs in practice settings.

Barriers and Benefits to the Use of Patient-Reported Outcome Measures in Routine Clinical Care: A Qualitative Study.

Patient-reported outcomes (PROs) provide information on how health care affects patient health and well-being and represent a patient-centered approach. Despite this potential, PROs are not widely used in clinical settings. Semi-structured focus groups were conducted with 3 stakeholder groups (patients, providers, and health care administrators) to determine the top 5 perceived barriers and benefits of PRO implementation. The Delphi technique was employed to obtain consensus and rank order responses. Patients perceived survey length to be important, whereas providers and administrators perceived time to collect data and patient health literacy, respectively, as the greatest barriers to PRO implementation. The greatest perceived benefits were the ability to track changes in clinical symptoms over time, improved quality of care, and better disease control among patients, providers, and administrators, respectively. These results may guide the development of novel frameworks for PRO implementation by addressing perceived barriers and building on the perceived benefits to encourage adoption of PROs.

Real-Time Assessment of Patient Reported Outcomes in Heart Failure Clinic

Introduction: Patient-reported outcomes (PROs) are commonly used in clinical trials to assess patient health-related quality of life (hrQoL), but PRO implementation in daily practice is rare. We sought to develop a novel approach to integrate PROs within routine clinical practice at a heart failure (HF) clinic. Methods and Results Technical implementation of PRO capture was facilitated by the University of Utah mEVAL Personal Health Assessment team. We deployed a computer program on portable computers (iPad) to collect PRO instruments of interest—Kansas City Cardiomyopathy Questionnaire & physical function, depression, fatigue, and satisfaction with social roles domains of Patient-Reported Outcomes Measurement Information System—PROMIS. We initiated an automated algorithm through which patients are identified at registration for clinic, provided with iPAD and asked to complete the PROs (Fig. 1A). Through secure data transfer, PROs are scored and made immediately available in the electronic health record (EHR) (Fig. 1B). We also conducted provider training in PRO score interpretation. In 2016, serial PRO assessments were done in 685 patients (age 60.1 ± 16.3 yrs, 66% male, average completion time 6.7 min), which represented a 58% completion rate among eligible patients. PRO results indicated marked reduction in hrQoL in a large number of the patients—Table 1. The original design was to collect PROs at 3 month intervals; early experience indicated that it was more useful to collect these at each visit and share the results with patients. This is expected to improve completion rates. Conclusion PRO capture during routine clinical care with real-time EHR uploads is feasible in a large HF outpatient population. Ongoing efforts will better determine how best to share this information with patients and will provide data regarding the utility of routine PRO use in clinical care. While PROs are being proposed as required metrics of quality of health care delivery, our approach intends to make these measures actionable in real-time clinical care.Table 1Scores of completed patient-reported outcome assessmentsInstrument NameSample SizeMedian Score25th Percentile75th PercentileKCCQ-12804573974PROMIS-Depression714504557PROMIS-Fatigue788554861PROMIS-Physical Function719413547PROMIS-Satisfaction Roles Activities791453951 Open table in a new tab

Feasibility of incorporating patient reported outcomes (PROs) into routine care for oropharyngeal carcinoma (OPC).

e21652 Background: We assessed the feasibility of using PROs as part of routine care to better understand the trajectory in quality of life (QOL) following treatment of OPC. Methods: The Memorial Sloan Kettering Cancer Center (MSK) head and neck disease management team (DMT) assembled a parsimonious paper survey composed of validated PRO measures (EORTC QLQ 30 and HN-35, Neck Dissection Impairment Index, Skindex-16, and COST-FACT) to assess QOL at baseline, immediately and 3 months post treatment. From Jan-May 2016, a DMT PRO coordinator identified patients with non-metastatic OPC and notified clinical teams to print the surveys to be completed in the waiting room. We assessed the feasibility of incorporating PROs into routine care across the DMT using this process by examining response rates (RR) and identifying potential barriers (i.e., regional site of treatment, number of treatment modalities, hospitalizations, demographic variables) to completing PROs. Results: Of 54 patients with non-metastatic OPC, 3 non-English speakers and 5 protocol patients were excluded. Median age was 61.3 years (43.8-78.4). Patients were mostly male (89%), married (74%) and presented with locally-advanced OPC (89%) due to HPV (89%). 89% received multimodality therapy (89%), of which 36 (88%) received chemoradiation, and nearly half (48%) were treated at MSK regional sites. The RR decreased substantially over time (Table 1). 2 patients died* and 17 patients were hospitalized within these 3 months. In bivariate analyses, no prespecified demographic or clinical barriers to completion of PROs were identified. On deeper investigation, decline in RR overtime resulted from not capturing change in scheduling, which occurs more frequently after treatment completion. Conclusions: Implementation of longitudinal PROs into routine care is feasible and generally acceptable by the patients, but requires a coordinated effort to sustain an acceptable RR. For future efforts, the project coordinator will use a portal messaging system to communicate directly with patients and use an electronic PRO format. [Table: see text]

Improving Cancer Care Through the Patient Experience: How to Use Patient-Reported Outcomes in Clinical Practice.

Poorly controlled symptoms are common and debilitating during cancer treatment and can affect functional status and quality of life, health care resource utilization, treatment adherence, and cancer survivorship. Historically, the patient experience, including symptoms during treatment, has not been tracked or documented in the patient health record. Measurement of patient-reported outcomes (PROs), including symptoms, is an essential component to cancer care focused on the illness impact to the patient and family. PROs can be useful at the individual level for monitoring and promoting symptom care both in the clinic and remotely and at the population level for aggregating population data for use in research and quality improvement initiatives. Implementation of PROs in cancer clinical care requires a carefully thought out process to overcome challenges related to integrating PROs into existing electronic health records and clinical work flow. Issues with implementing PRO collection may include making decisions about measurement tools, modes of delivery, frequency of measurement, and interpretation that are guided by a clarification of the purpose for collecting PROs. We focus on three aspects of PRO use: (1) improving care for individual patients, (2) analyzing aggregated data to improve care and outcomes overall, and (3) considerations in implementing PRO collection.

Montreal Accord on Patient-Reported Outcomes (PROs) use series – Paper 8: patient-reported outcomes in electronic health records can inform clinical and policy decisions

BackgroundGiven that the goal of health care systems is to improve and maintain the health of the populations they serve, the indicators of performance must include outcomes that are meaningful to patients. The growth of health technologies provides an unprecedented opportunity to integrate the patient voice into clinical care by linking electronic health records (EHRs) to patient-reported outcome (PRO) data collection. However, PRO data must be relevant, meaningful, and actionable for those who will have to invest the time and effort to collect it. ObjectiveIn this study, we highlight opportunities to integrate PRO data collection into EHRs. We consider how stakeholder perspectives should influence the selection of PROs and ways to enhance engagement in and commitment to PRO implementation. We propose a research and policy agenda to address unanswered questions and facilitate the widespread adoption of PRO data collection into EHRs. DiscussionBuilding a learning health care system that gathers PRO data in ways that can inform individual patient care, quality improvement, and comparative effectiveness research has the potential to accelerate the application of new evidence and knowledge to patient care.

Do Patients and Physicians Agree When They Assess Quality of Life?

Patient and physician agreement on the most significant symptoms is associated with treatment outcomes and satisfaction with care. Thus, we sought to assess patient and physician agreement on patient-reported quality of life (QoL), and whether patient-related variables predict disagreement. In this cross-sectional, multisite study, patients and physicians completed the FACT-BMT at day 90. Agreement was analyzed with the intraclass coefficient correlation (ICC). Rates of underestimation and overestimation were calculated. Logistic regression models identified predictors of disagreement. We analyzed 96 pairs of questionnaires completed by 96 patients and 11 physicians. The patients' median age was 54 years, 52% were men, and 52% had undergone allogeneic hematopoietic cell transplantation (HCT). The physicians' median age was 42, 64% were men, and they had worked in the HCT field for an average of 12 years. Agreement on QoL was moderate (ICC = .436). Exploratory analyses revealed poor agreement for emotional (ICC = .092) and social (ICC = .270) well-being and moderate agreement for physical (ICC = .457), functional (ICC = .451), and BMT concerns (ICC = .445). Patients' well-being was underestimated by physicians in 41% to 59% of the categories of well-being parameters, and overestimated in 10% to 24%. Patient's anxiety predicted less disagreement in all scales except in social well-being, for which nonsignificant associations were observed. Patient-related variables explained 12% to 19% of the variance in disagreement across well-being scales. Patient and physician agreement on QoL was suboptimal, particularly in emotional and social well-being. The implementation of patient-reported outcomes in the daily care of HCT recipients may contribute to improving patient-centered care.

Use of patient-reported outcome measures in Quality Oncology Practice Initiative registered practices: Results of a national survey.

81 Background: Measuring patient-reported outcomes (PROs) improves the experience of care and reduces the burden of disease for cancer patients. Professional societies, including ASCO, encourage the collection of PROs, but little is known about how many practices collect PROs and, if so, which PROs are measured and what challenges are met in implementation. Methods: We surveyed Quality Oncology Practice Initiative (QOPI) registered practices to understand the current state of PROs use and identify areas where greater support for PROs implementation may be needed. One respondent from each practice was invited to complete an online survey that assessed views regarding PROs and challenges with implementation. Non-users were asked about their interest in and barriers to future collection of PROs. Results: Of 233 practices that viewed the request to participate, 109 completed the survey (47%). Most responding practices (73%) currently collect PROs. Of these, 79% are affiliated with hospitals/medical centers, 50% have > 10 advanced practice providers, and 94% use electronic health records. PROs users see a higher volume of patients per week than non-users (p < 0.01). QOPI-registered practices collect a wide variety of PROs, including validated and home-grown questionnaires. The most commonly measured PROs are distress (78%), symptom assessment (76%), and experience/satisfaction (70%). The most frequently reported implementation challenges were the same for users and non-users: patient unwillingness to complete questionnaires (34%) and insufficient staff to support collection (29%). Despite only moderate perceived patient willingness to answer PROs (2.67/5), 79% of all practices believe collecting PROs is a high priority. Conclusions: While many QOPI practices have implemented PROs, substantial barriers to implementation are apparent and may be limiting more wide-spread adoption. Efforts to identify which PROs most improve care quality are sorely needed. Sharing best practices on improving patient/provider buy-in and enabling efficient integration of PROs into clinic workflow may also facilitate adoption and maximize the utility of PROs for oncology practices.

Improving Cancer Care Through the Patient Experience: How to Use Patient-Reported Outcomes in Clinical Practice

Poorly controlled symptoms are common and debilitating during cancer treatment and can affect functional status and quality of life, health care resource utilization, treatment adherence, and cancer survivorship. Historically, the patient experience, including symptoms during treatment, has not been tracked or documented in the patient health record. Measurement of patient-reported outcomes (PROs), including symptoms, is an essential component to cancer care focused on the illness impact to the patient and family. PROs can be useful at the individual level for monitoring and promoting symptom care both in the clinic and remotely and at the population level for aggregating population data for use in research and quality improvement initiatives. Implementation of PROs in cancer clinical care requires a carefully thought out process to overcome challenges related to integrating PROs into existing electronic health records and clinical work flow. Issues with implementing PRO collection may include making decisions about measurement tools, modes of delivery, frequency of measurement, and interpretation that are guided by a clarification of the purpose for collecting PROs. We focus on three aspects of PRO use: (1) improving care for individual patients, (2) analyzing aggregated data to improve care and outcomes overall, and (3) considerations in implementing PRO collection.

Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications.

The capture of adequate treatment outcomes and quality of life (QOL) of advanced breast cancer patients in clinical routine represents a great challenge. Patient-reported outcomes (PROs) are data elements directly reported by patients about experiences with care, including symptoms, functional status, or quality of life. There is growing interest in the medical community for the evaluation and implementation of PROs of adverse events (PRO-AEs). Recent interest in PROs in health care has evolved in the context of patient centeredness. Our primary objective was to identify trials that had implemented PRO-AEs in the breast cancer treatment setting, thereby demonstrating its feasibility. We aimed to identify published studies that used patient reports to assess AEs during and after breast cancer treatment, to identify clinician underreported and modifiable AEs that are important to patients, and to analyze the feasibility and usefulness of PRO instrument implementation in everyday oncological practice with special attention given to electronic-based PRO instruments. We conducted a systematic search of PubMed for studies that used PRO instruments to assess AEs of breast cancer treatment in the metastatic and adjuvant settings. Two authors independently reviewed the search results and decided which studies fully met the predefined inclusion criteria. The search yielded 606 publications. The two reviewers found that 9 studies met the inclusion criteria. Three AEs were identified as important to patients but inadequately reported by health care providers, namely hot flushes, vaginal dryness, and weight gain. PROs and PRO-AEs are the consequence of contemporary concepts of patient-centered medicine and the growing feasibility, utility, and implications of collecting data using modern technology. Furthermore, the willingness of patients to utilize innovative applications for their own health has been increasing in parallel to the enhanced impact of the World Wide Web. Especially, the coverage of the metastatic situation promises numerous findings on the structure and quality of health care, enabling implementation of individually tailored interventions. Remote electronic self-reporting (i.e., home reporting) is feasible and is associated with high compliance levels.

Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities.

Patient-reported outcomes (PROs) are reports of the status of a patient's health condition that come directly from the patient. While PRO measures are a well-developed technology with robust standards in research, their use for informing healthcare decisions is still poorly understood. We review relevant examples of their application in the provision of healthcare and examine the challenges associated with implementing PROs in clinical settings. We evaluate evidence for their use and examine barriers to their uptake, and present an evidence-based framework for the successful implementation of PROs in clinical practice. We discuss current and future developments for the use of PROs in clinical practice, such as individualized measurement and computer-adaptive testing.

Stakeholder Engagement in a Patient-Reported Outcomes (PRO) Measure Implementation: A Report from the SAFTINet Practice-based Research Network (PBRN)

Patient-reported outcome (PRO) measures offer value for clinicians and researchers, although priorities and value propositions can conflict. PRO implementation in clinical practice may benefit from stakeholder engagement methods to align research and clinical practice stakeholder perspectives. The objective is to demonstrate the use of stakeholder engagement in PRO implementation. Engaged stakeholders represented researchers and clinical practice representatives from the SAFTINet practice-based research network (PBRN). A stakeholder engagement process involving iterative analysis, deliberation, and decision making guided implementation of a medication adherence PRO measure (the Medication Adherence Survey [MAS]) for patients with hypertension and/or hyperlipidemia. Over 9 months, 40 of 45 practices (89%) implemented the MAS, collecting 3,247 surveys (mean = 72, median = 30, range: 0 - 416). Facilitators included: an electronic health record (EHR) with readily modifiable templates; existing staff, tools and workflows in which the MAS could be integrated (e.g., health risk appraisals, hypertension-specific visits, care coordinators); and engaged leadership and quality improvement teams. Stakeholder engagement appeared useful for promoting PRO measure implementation in clinical practice, in a way that met the needs of both researchers and clinical practice stakeholders. Limitations of this approach and opportunities for improving the PRO data collection infrastructure in PBRNs are discussed.