BackgroundTo explore the existing evidence of the real-world implementation of patient-reported outcomes (PROs) in oncology clinical practice and address two aims: (1) summarize available evidence of PRO use in clinical practice using a framework based on the International Society for Quality of Life Research (ISOQOL) PRO Implementation Guide; and (2) describe reports of real-world, standardized PRO administration in oncology conducted outside of scope of a research study.MethodsA Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was developed to guide the systematic literature review (SLR) that was conducted in MEDLINE and Embase databases. A two step search strategy was implemented including two searches based on previously completed reviews. Studies published from 2006 to 2017 were synthesized using a framework based on the ISOQOL PRO Implementation Guide.ResultsAfter screening 4427 abstracts, 36 studies met the eligibility criteria. Most elements of the ISOQOL PRO Implementation Guide were followed. Two notable exceptions were found: 1) providing PRO score interpretation guidelines (39% of studies); and 2) providing patient-management guidance for addressing issues identified by PROs (25% of studies). Of the 22 studies with an intervention component, 19 (86%) reported intervention effects on study outcomes. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) was the most commonly used PRO (n = 10, 28%); use of 38 other PRO measures was also reported. Only three studies (8%) reported real-world PRO implementation.ConclusionReports of real-world PRO implementation are limited. Reports from studies conducted in clinical settings suggest gaps in information on PRO score interpretation and the use of PRO results to inform patient management. Before the promise of practice-based PRO assessment in oncology can be truly realized, investigators need to advance the state-of-the-art of real-time PRO score interpretation as well as developing guidance on how to use PRO insights to drive clinically-meaningful patient-management strategies.
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Background Discussions regarding palliative care and end‐of‐life care issues are frequently delayed past the time of usefulness, resulting in unwanted medical care. We sought to develop a patient‐reported outcome (PRO) instrument that allows patients to voice their symptom burdens and facilitate timing of discussions. Subjects, Materials, and Methods A seven‐item PRO instrument (Cota Patient Assessed Symptom Score‐7 item [CPASS‐7]) covering physical performance status, pain, burden, and depression was administered (September 2015 through October 2016) with correlation to overall survival, correcting for time to complete survey since diagnosis. Results A total of 1,191 patients completed CPASS‐7 at a median of 560 days following the diagnosis of advanced cancer. Of these patients, 49% were concerned that they could not do the things they wanted; 35% reported decreased performance status. Financial toxicity was reported by 39% of patients, with family burdens noted in 25%. Although depression was reported by 15%, 43% reported lack of pleasure. Pain was reported by 33%. The median CPASS‐7 total symptom burden score was 16 (possible 0–112). With a median follow‐up of 15 months from initial survey, 46% had died. Patients with symptom burden scores <29 and ≥29 had a 6‐month overall survival rate of 87% and 67%, respectively, and 12‐month survival rates of 72% and 50%. A one‐point score increase resulted in a 1.8% increase in expected hazard. Conclusion Patients with advanced cancer with higher levels of symptom burden, as self‐reported on the CPASS‐7, had inferior survival. The PRO facilitates identification of patients appropriate for reassessment of treatment goals and potentially palliative and end‐of‐life care in response to symptom burden concerns. Implications for Practice A seven‐item patient‐reported outcome (PRO) instrument was administered to 1,191 patients with advanced cancers. Patients self‐reporting higher levels of physical and psychological symptom burden had inferior overall survival rates. High individual item symptom PRO responses should serve as a useful trigger to initiate supportive interventions, but when scores indicate global problems, discussions regarding end‐of‐life care might be appropriate.
Background: Shared decision making (SDM) is a process in which health care providers and patients relate to and influence each other as they collaborate in making decisions about patients' health care. Hypothesized as a means to improve quality of care, successful applications of SDM in routine cancer care have not been widely documented.
261 Background: Acute myeloid leukemia (AML) is a rare, but deadly hematological, disease with 20,830 new cases estimated in 2015 in the United States (US). As new treatments emerge, quality measures (QMs) will become important to assess the value of care. Our aim was to evaluate the current US AML QM landscape. Methods: We reviewed literature and online resources (eg, National Quality Measures Clearinghouse, Centers for Medicare & Medicaid Services, etc.) published within the last 5 years to identify AML-specific and AML-related QMs. All QMs were categorized using a “continuum of care” framework according to the 5 stages of AML: 1) symptom assessment, 2) diagnosis/risk stratification, 3) initial treatment, 4) monitoring/additional treatment, and 5) advanced/late stage care. Quality measures were categorized by the measure type (eg, process or outcome measure) and use by the Centers for Medicare & Medicaid Services (CMS). Results: In total, 30 QMs were identified: 1 leukemia-specific QM and 29 general oncology QMs. The leukemia-specific QM is a clinician-level process measure that evaluates the percentage of patients aged ≥ 18 years with a diagnosis of myelodysplastic syndrome or acute leukemia who had baseline bone marrow cytogenetic testing performed. Among the 29 general QMs: 8 are specific to stem cell transplantation, 13 are specific to chemotherapy, and 8 are general to oncology. Across the AML continuum of care: 2 QMs focus on symptom assessment, 1 supports diagnosis/risk stratification, 11 are for initial treatment, 9 for monitoring/additional treatment, and 7 for late-stage care. Twenty-seven QMs are based on process of care: 1 addresses resource utilization and 2 are outcomes based. The single leukemia-specific QM is used in CMS quality improvement programs, along with 3 other oncology-related QMs. Conclusions: While only one identified QM was specific to leukemia, other general oncology QMs may also apply. Unfortunately, QMs addressing AML-related morbidity and mortality are still lacking. Research into patient-centered communication, shared decision-making, patient-reported outcomes and resource use by AML patients may inform development of new QMs. Sponsorship: This research was funded by Astellas Pharma, Inc.
145 Background: Patient-provider communication is recognized as allowing patients to become more active within the treatment process and treatment related decisions. This paradigm shift of involving patients as active stakeholders in their care promotes a patient-centered approach to healthcare, and may positively impact outcomes. Two tools for use in clinical practice were developed to aid patient-provider communication in oncology: Assessing Treatment Goals and Patient Education. This study aimed to evaluate the face and content validity of these tools. Methods: A non-interventional, cross-sectional, qualitative cognitive interview study was conducted in the US with patients with non-hodgkin’s lymphoma (n = 6), lung cancer (n = 7) and colon cancer (n = 7) and matched caregivers (n = 10). Interviews with oncologists (n = 5) and oncology nurses (n = 5) were also conducted. During the interviews, participants completed both tools as a ‘think-aloud’ process and were asked about the relevance and understanding of the instructions, questions, and response options, from the patient and healthcare provider perspective. Results: Ademographically and clinically diverse participant sample was recruited. Feedback from participants confirmed that the Assessing Treatment Goals tool questions were understood and considered relevant. Minor modifications were proposed including the addition of a question regarding the involvement of family and friends in healthcare decision-making. Similarly, the Patient Education tool topics were well understood and relevant. Minor modifications to simplify topic wording were proposed. Furthermore, the empirical data led to adding two topics: ‘body image’ and ‘beyond cancer care’. No topics were suggested for deletion from this tool. Patients and healthcare providers considered both tools to be valuable for communication. Conclusions: Feedback from participants supported the face and content validity of both tools with minor modifications. The next phase of research is to pilot the tools in clinical practice and assess for usability and feasibility. It is hoped that when used in clinical practice these tools will facilitate greater patient-provider communication and increased satisfaction with care.
273 Background: Prostate cancer (PCa) is the leading cancer for men in the United States (US) and identified by the Centers for Medicare & Medicaid Services (CMS) as one of the top 20 high-impact Medicare conditions experienced by beneficiaries. Thus, there is increasing focus by stakeholders to measure and achieve high-value, quality care in PCa. However, quality measurement is particularly difficult in oncology. Our aim was to assess the current landscape of PCa quality measures (QMs) in the US. Methods: Published literature and online resources from the past 5 years were reviewed to identify PCa QMs and general oncology QMs relevant to PCa. PCa QMs were categorized using a “continuum of care” framework across 5 stages: 1) symptom assessment and screening; 2) diagnosis and risk stratification; 3) initial treatment; 4) monitoring and additional treatment; and 5) advanced- or late-stage care. Finally, PCa QMs were evaluated for their type (eg. process, outcomes), and use by CMS. Results: We identified 16 PCa-specific QMs and 20 general oncology QMs relevant to PCa. The majority of PCa QMs were developed by the American Medical Association–Physician Consortium for Performance Improvements (6 measures) and the Michigan Urological Surgery Improvement Collaborative (6 measures). There are 3 QMs for symptom assessment and screening, 5 QMs for diagnosis and risk stratification, 6 QMs for initial treatment, 2 QMs for monitoring and additional treatment, and 0 QMs for advanced- or late-stage care. Fourteen PCa QMs focus on process of care, but only 2 PCa QMs address outcomes. Nine PCa QMs are part of CMS quality improvement programs, 6 of which are reportable through the Michigan Urological Surgery Improvement Collaborative. Three new PCa QMs are under consideration by CMS. Conclusions: We found few PCa QMs that capture outcomes of patient experience or care, and no PCa-specific QMs available for advanced disease and late-stage care, demonstrating a need to better define quality in this setting. Opportunities to increase the focus on innovative, real-world data-generation strategies, such as PCa disease registries that collect clinical outcomes, patient preferences, and comorbidities, may inform stakeholder development and adoption of new QMs in the US.
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