The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.

The National Quality Forum (NQF), a national organization that has been deeply involved in moving the quality-improvement agenda forward for many years (http://www.qualityforum.org), endorses and promulgates quality-ofcare and performance measures that various provider groups, regulatory agencies, payers and insurers, and others can use for accountability and quality improvement activities. In 2012 and 2013, the organization began an initiative to find PROs that might be added to its extensive collection of performance measures. Its National Voluntary Consensus Standards for Patient Outcomes: A Consensus Report defined outcomes as being important because they "reflect the reason that an individual seeks healthcare services. " 1 The individual patient's voice in many performance measures, however, has largely been missing. Few ways to assess performance are available at the organizational level, even though patients are often the best able to report on the experiences and results of their individual care.To fill that gap, NQF convened an expert panel at two public meetings and, as background for its deliberations, commissioned two authoritative background papers. This monograph is a revised and updated version of the first of these two papers, which provided the background on issues about selecting PROs for use in a variety of applications pertinent to the NQF mission and activities. The second paper, Patient-Reported Outcomes in Performance Measurement, 9 dealt with issues relating to processes for endorsing performance measures that reflect the end results (ultimate outcomes) of health care. Its primary focus was on accountable health care organizations.This monograph applies the conceptual and organizational frameworks that NQF has pioneered in the past decade or so. NQF distinguishes PROs, patientreported outcome measures (or PROMs), and patient-reported outcome performance measures (or PRO-PMs). NQF endorses PRO-PMs through transparent and consensus-based procedures. This monograph addresses the PROs that are likely to be used to inform PRO measures (PROMs) that would underpin scientifically acceptable and feasible performance measures. We do not address issues with identifying, evaluating, or endorsing PRO-PMs for health care organizations or clinicians. Key Concept DefinitionPatient A person who is receiving health care services or using long-term health care support services. Patientreported outcome (PRO)Any information on the outcomes of health care obtained directly from patients without modification by clinicians or other health care professionals. For purposes of this monograph, we use this term broadly to include any patient input, whether or not it is standardized or gathered with a structured questionnaire. Patientreported outcome measure (PROM)Any standardized or structured questionnaire regarding the status of a patient's health condition, health behavior, or experience with health care that comes directly from the patient (i.e., a PRO). The use of a structured, standardized tool such as a PROM wi...

One of the goals of the NIH Toolbox for Assessment of Neurological and Behavioral Function was to identify or develop brief measures of emotion for use in prospective epidemiologic and clinical research. Emotional health has significant links to physical health and exerts a powerful effect on perceptions of life quality. Based on an extensive literature review and expert input, the Emotion team identified 4 central subdomains: Negative Affect, Psychological Well-Being, Stress and Self-Efficacy, and Social Relationships. A subsequent psychometric review identified several existing self-report and proxy measures of these subdomains with measurement characteristics that met the NIH Toolbox criteria. In cases where adequate measures did not exist, robust item banks were developed to assess concepts of interest. A population-weighted sample was recruited by an online survey panel to provide initial item calibration and measure validation data. Participants aged 8 to 85 years completed self-report measures whereas parents/guardians responded for children aged 3 to 12 years. Data were analyzed using a combination of classic test theory and item response theory methods, yielding efficient measures of emotional health concepts. An overview of the development of the NIH Toolbox Emotion battery is presented along with preliminary results. Norming activities led to further refinement of the battery, thus enhancing the robustness of emotional health measurement for researchers using the NIH Toolbox. Neurology In everyday terms, the word "emotion" evokes connotations of strong feelings, often negative and distressing when they tax our capacity to maintain our poise. It is unpleasant when we are extended beyond our usual resources by stressful life events including poverty, unemployment, oppression, discrimination, and disease. However, positive emotions can be reflections of well-being in our lives, and positive social relationships can buffer stress and enhance health. Recognizing the full spectrum of emotional life and its impact on health, the mandate for the NIH Toolbox was to develop assessments with a broad focus, beyond just negative emotion, or emotional distress. The original Request for Proposals alluded to several additional aspects of the experience and expression of emotion relevant to health in the general population including the importance of psychological well-being, the role of important aspects of positive functioning, such as adaptability, resilience, and self-efficacy, and the importance of the interpersonal and social context in which emotions arise and may be expressed.Feedback provided through an NIH Toolbox Expert Request for Information (RFI) was also consistent with this desire for a broad emphasis on emotional health. As part of this RFI, we obtained input from 147 experts (64% of 232 invited experts), including key opinion leaders from the NIH research program staff and NIH-funded investigators with a broad focus in neurologic and behavioral

Objective The quality of our daily social interactions – including perceptions of support, feelings of loneliness, and distress stemming from negative social exchanges – influence physical health and well-being. Despite the importance of social relationships, brief yet precise, unidimensional scales that assess key aspects of social relationship quality are lacking. As part of the NIH Toolbox for the Assessment of Neurological and Behavioral Function, we developed brief self-report scales designed to assess aspects of social support, companionship, and social distress across age cohorts. This report details the development and psychometric testing of the adult NIH Toolbox Social Relationship scales. Methods Social relationship concepts were selected, and item sets were developed and revised based on expert feedback and literature review. Items were then tested across a community-dwelling U.S. internet panel sample of adults aged 18 and above (N=692) using traditional (classic) psychometric methods and item response theory (IRT) approaches to identify items for inclusion in 5–8 item unidimensional scales. Finally, concurrent validity of the newly-developed scales was evaluated with respect to their inter-relationships with classic social relationship validation instruments. Results Results provide support for the internal reliability and concurrent validity of resulting self-report scales assessing Emotional Support, Instrumental Support, Friendship, Loneliness, Perceived Rejection, and Perceived Hostility. Conclusion These brief social relationship scales provide the pragmatic utility and enhanced precision needed to promote future epidemiological and social neuroscience research on the impact of social relationships on physical and emotional health outcomes.

There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrology (SONG) Initiative was formed to identify core outcomes that are critically important to patients and health professionals, to be reported consistently across trials. We convened a SONG Implementation Workshop to discuss the implementation of core outcomes. Eighty-two patients/caregivers and health professionals participated in plenary and breakout discussions. In this report, we summarize the findings of the workshop in two main themes: socializing the concept of core outcomes, and demonstrating feasibility and usability. We outline implementation strategies and pathways to be established through partnership with stakeholders, which may bolster acceptance and reporting of core outcomes in trials, and encourage their use by end-users such as guideline producers and policymakers to help improve patient-important outcomes.

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Fatigue, pain, distress, and anorexia are four commonly encountered symptoms in cancer. To evaluate the usefulness of a single-item screening for these symptoms, 597 ambulatory outpatients with solid tumors were administered a self-report screening instrument within the first 12 weeks of chemotherapy. Patients rated the severity of each symptom on a 0-10 scale, at its worst over the past three days, with higher ratings associated with higher symptom levels. From this sample, 148 patients also completed a more comprehensive assessment of these symptoms. Two criteria were used to determine optimal cut-off scores on the screening items: 1) the sensitivity and specificity of each screening item to predict clinical cases using receiver-operating characteristics analysis and 2) the proportion of patients at each screening score who reported that some relief of the target symptom would significantly improve their life. Optimal cut-off scores ranged from 4 to 6 depending on the target symptom (area under the curve range=0.68-0.88). Use of single-item screening instruments for fatigue, pain, distress, and anorexia may assist routine clinical assessment in ambulatory oncology practice. In turn, such assessments may improve identification of those at risk of morbidity and decreased quality of life due to excess symptom burden.

Cancer fatigue has been defined and described as an important problem. However, few studies have assessed the relative importance of fatigue compared with other patient symptoms and concerns. To explore this issue, the authors surveyed 534 patients and 91 physician experts from 5 NCCN member institutions and community support agencies. Specifically, they asked patients with advanced bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, or prostate cancer or lymphoma about their "most important symptoms or concerns to monitor." Across the entire sample, and individually for patients with 9 cancer types, fatigue emerged as the top-ranked symptom. Fatigue was also ranked most important among patients with 10 of 11 cancer types when asked to rank lists of common concerns. Patient fatigue ratings were most strongly associated with malaise (r = 0.50) and difficulties with activities of daily living, pain, and quality of life. Expert ratings of how much fatigue is attributable to disease versus treatment mostly suggested that both play an important role, with disease-related factors predominant in hepatobiliary and lung cancer, and treatment-related factors playing a stronger role in head and neck cancer.