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Background Peanut allergy (PA) places significant burden on peanut-allergic individuals and their families, yet limited research in the United States has quantitatively examined the impact on peanut-allergic individuals and their families’ health-related quality of life (HRQoL). The Peanut Allergy Burden Study (PABS) aimed to quantify the impact of PA on the general and disease-specific HRQoL of children, adolescents, and adults with PA, as well as caregivers of children with PA. Methods A cross-sectional survey design was employed to examine the real-world impact of PA in children, adolescents, and adults with PA, and caregivers of children with PA. Results Of 153 adult patients, 102 adolescents, and 382 caregivers of peanut-allergic children (n = 382), 6.8% and 24.8% of participants indicated being dissatisfied or somewhat dissatisfied, respectively, with current approaches to avoid or prevent PA reactions. Approximately two-thirds of patients and caregivers indicated that PA interferes at least somewhat with daily living. In terms of general HRQoL, adolescents, adult patients, and caregivers indicated that mental/psychosocial health was more problematic than physical health. PA patients and caregivers indicated worse HRQoL in all domains compared to healthy samples, and worse overall HRQoL, psychosocial, emotional, and social functioning than a sample of chronically ill patients. Results from the allergy-specific HRQoL measures showed that adolescents experienced greater impairment in overall HRQoL due to PA and in allergen avoidance and dietary restriction than adults. Conclusion PA negatively affects the general and PA-specific HRQoL of both patients and caregivers. The high emotional and psychosocial burden, in particular, demonstrates significant unmet need for patients with PA and their caregivers. Future work on treatment and preventive options to improve HRQoL for PA patients, particularly adolescents and their families, is needed.

Background To 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. Methods A 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. Results After 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. Conclusion Reports 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.

Background The clinical course of ulcerative colitis (UC) and the effects of treatment are assessed through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of UC in clinical trials through direct report from patient ratings. Design The UC-PRO/SS was developed by collecting data from concept elicitation (focus groups, and individual interviews), then refined through a process of cognitive interviews of 57 UC patients. Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were evaluated in an observational, four-week study of adults with mild to severe UC (N = 200). Results Findings from qualitative focus groups and interviews identified nine symptom items covering bowel and abdominal symptoms. The final UC-PRO/SS daily diary includes two scales: Bowel S&S (six items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 80 and 0.66, respectively); reproducibility (intraclass correlation coefficient = 0.81, 0.71) and validity, including moderate-to-high correlations with the Partial Mayo Score (0.79; 0.45) and Inflammatory Bowel Disease Questionnaire (IBDQ) total score (− 0.70; − 0.61). Scores discriminated by level of disease severity, as defined by the Partial Mayo Score, Patient Global Rating, and Clinician Global Rating (p

Background The clinical course of Crohn’s disease (CD) and the effect of its treatment are monitored through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Crohn’s Disease Patient-reported Outcomes Signs and Symptoms (CD-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of CD through direct report from patient ratings. Methods The CD-PRO/SS was developed based on data from concept elicitation (focus groups, interviews; n = 29), then refined through cognitive interviews of CD patients (n = 20). Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were examined using secondary analyses of baseline and two-week clinical trial data of adults with moderate-to-severe CD (n = 238). Results Findings from qualitative interviews identified nine S&S items covering bowel and abdominal symptoms. The final CD-PRO/SS daily diary includes two scales: Bowel S&S (three items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 0.74 and 0.67, respectively); reproducibility (intraclass correlation coefficient > 0.80), and validity, with the last including moderate correlations with the Inflammatory Bowel Disease Questionnaire bowel symptom score and select items (ranging from r = 0.43–0.54). Scores distinguished patients categorized by patient global ratings of disease severity (p

Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions. While there have been significant strides by key health care stakeholders to further the development and use of PROs, there are a number of challenges limiting more widespread use. In light of these current challenges and the potential for PROs to improve health care quality and value, on October 19, 2017, the Academy of Managed Care Pharmacy convened a forum of key stakeholders representing patients, payers, providers, government, and pharmaceutical companies to discuss and identify solutions to the current challenges and barriers to further use of PROs. These discussions informed the development of participants' ideal future state in which PROs maximize the goals of all health care stakeholders and the actionable steps required to make the future state a reality. While stakeholders shared unique perspectives throughout the forum, they had consensus on 2 overarching issues: the importance of PROs in defining value, improving patient care, and implementing value-based payment models and the need for strong organizational and operational systems to achieve optimal adoption and use. Participants identified several key challenges in PRO use and adoption: achieving a representative patient population, inclusion of PRO data in medication labels, the necessity for both standardized and customizable PROs, and operational and organizational barriers to collecting and analyzing PROs. To overcome these challenges, participants recommended that manufacturers should engage key stakeholders early and throughout the drug development process to ensure the most valid and representative PROs and patient populations will be included. To streamline the PRO collection process, participants suggested engaging pharmacists and other providers who may have more frequent interaction with patients. Participants also recommended that PRO collection and analysis should use common technology platforms, streamline components of clinician care to reduce workflow, and be integrated with claims data to provider payers a better understanding of patient health in real time. Finally, additional work should be done to develop patient-reported outcome measures that contain relevant measures for all healthcare stakeholders. While significant challenges remain in PRO development and adoption, participants agreed that greater use can only be achieved through collaboration and patient-centered care.The AMCP Partnership Forum titled "Improving Quality, Value, and Outcomes with Patient-Reported Outcomes" and the development of this proceedings report were supported by Amgen, Boehringer Ingelheim Pharmaceuticals, Genentech, GlaxoSmithKline, Novartis Pharmaceuticals, Novo Nordisk, Precision for Value, Premier, Sanofi, Takeda Pharmaceuticals USA, and Xcenda.

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. OBJECTIVE The objective of this study was to examine the literature to determine if elements of SDM implementation between cancer patients and their clinicians were more or less successful at improving the quality of care and health outcomes. METHODS A systematic literature search of SDM approaches and outcomes in cancer care was conducted using PubMed and EMBASE. An integrative model for SDM was used to classify elements included in SDM intervention studies and the resulting outcomes. RESULTS From 1,018 unique publications, 23 articles meeting eligibility criteria were included. Only three studies addressed elements of patient-clinician interaction as part of the study objectives. Interventions included decision aid (DA) evaluation (n=22) and clinician communication training (n=1). SDM elements commonly included were: defining/explaining the problem (n=23); presenting options (n=19); discussing pros and cons (n=17); assessing patient priorities and preferences (n=17); clinician knowledge and recommendations (n=15); and making or deferring treatment decisions (n=12). The most frequently-measured outcomes were patient-reported outcomes including treatment preference or decision (n=12), decisional conflict (n=10), patient satisfaction (n=10), patient participation (n=9), and patient knowledge (n=7). No clear patterns demonstrating relationships between SDM elements and outcomes were identified. Information on how patients and clinicians utilized DA information to promote SDM was limited. CONCLUSIONS Evaluation of SDM in cancer care has been increasing. However, the term “SDM” was generally applied to studies that focused on the development and/or evaluation of DAs which limited the current analyses to a review of SDM elements as part of the DAs. Most studies did not include a qualitative or quantitative measure of SDM specific to patient-clinician communication and interaction. Instead, there was an underlying assumption that SDM occurred organically with DA implementation. Without a qualitative or quantitative measure of SDM, identification of successful SDM elements and their relationships to patient outcomes remains unclear. Additional research is warranted on SDM implementation and measurement in real-world cancer care settings.

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.