Objective Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care, yet current measures have been limited by a lack of precision, standardization and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS™) provides item banks that offer the potential for PRO measurement that is efficient (minimizes item number without compromising reliability) flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly-studied PROs. We report results from the first large-scale testing of PROMIS items. Study Design and Setting Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting sub-sample was created reflecting demographics proportional to the 2000 U.S. census. Results Using item response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental and social health, along with a 10-item global health scale. Short forms from each bank were developed and compared to the overall bank as well as with other well-validated and widely accepted (“legacy”) measures. All item banks demonstrated good reliability across the majority of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures. Conclusion PROMIS item banks and their short forms provide evidence they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations.

The experience of HSCT for a malignant disease has a wide-ranging, longstanding, and profound impact on adult recipients. Relative to healthy controls, HSCT survivors reported poorer physical, psychological, and social functioning but, conversely, more psychological and interpersonal growth, differences that appeared to persist many years after HSCT.

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.

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...

Purpose To develop a social health measurement framework, to test items in diverse populations and to develop item response theory (IRT) item banks. Methods A literature review guided framework development of Social Function and Social Relationships sub-domains. Items were revised based on patient feedback, and Social Function items were field-tested. Analyses included exploratory factor analysis (EFA), confirmatory factor analysis (CFA), two-parameter IRT modeling and evaluation of differential item functioning (DIF). Results The analytic sample included 956 general population respondents who answered 56 Ability to Participate and 56 Satisfaction with Participation items. EFA and CFA identified three Ability to Participate sub-domains. However, because of positive and negative wording, and content redundancy, many items did not fit the IRT model, so item banks do not yet exist. EFA, CFA and IRT identified two preliminary Satisfaction item banks. One item exhibited trivial age DIF. Conclusion After extensive item preparation and review, EFA-, CFA- and IRT-guided item banks help provide increased measurement precision and flexibility. Two Satisfaction short forms are available for use in research and clinical practice. This initial validation study resulted in revised item pools that are currently undergoing testing in new clinical samples and populations.

Objective To develop psychometrically sound, culturally relevant and linguistically equivalent English and Spanish self-report measures of social health guided by a comprehensive conceptual model and applicable across chronic illnesses. Methods The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health Workgroup implemented a mixed methods approach to evaluate earlier results (v1.0); expand and refine domain definitions and items; translate items into Spanish; and obtain qualitative feedback. Computer-based and paper/pencil questionnaire administration was conducted with a variety of U.S. respondent samples during 2009–2012. Analyses included exploratory factor analysis (EFA), confirmatory factor analysis (CFA), two-parameter logistic item response theory (IRT) modeling, evaluation of differential item functioning (DIF), and evaluation of criterion and construct validity. Results Qualitative feedback supported the conceptualization of the Social Health domain framework (Social Function and Social Relationships sub-components). Validation testing participants (n=2,208 English; n=644 Spanish) were diverse in terms of gender, age, education and ethnicity/race. EFA, CFA and IRT identified seven unidimensional factors with good model fit. There was no DIF by language, and good evidence of criterion and construct validity. Conclusions PROMIS English and Spanish language instruments (v2.0), including computer-adaptive tests and fixed-length short forms, are publicly available for assessment of Social Function (Ability to Participate in Social Roles and Activities, and Satisfaction with Social Roles and Activities) and Social Relationships (Companionship; Emotional, Informational and Instrumental Support; and Social Isolation). Measures of social health will play a key role in applications that use ecologic (or determinants of health) models that emphasize how patients’ social environments influence their health.

Introduction Discussions about sexual health are uncommon in clinical encounters, despite the sexual dysfunction associated with many common health conditions. Understanding of the importance of sexual health and sexual satisfaction among US adults is limited. Aim To provide epidemiologic data on the importance of sexual health for quality of life and people’s satisfaction with their sex lives and to examine how each is associated with demographic and health factors. Methods Data are from a cross-sectional, self-report questionnaire from a sample of 3515 English-speaking US adults recruited from an online panel that uses address-based probability sampling. Main Outcome Measures We report ratings of importance of sexual health to quality of life (single item with 5-point response) and the PROMIS® Satisfaction with Sex Life score (5 items, each with 5-point responses, scores centered on the US mean). Results High importance of sexual health to quality of life was reported by 62.2% of men (95% CI, 59.4%–65.0%) and 42.8% of women (95% CI, 39.6%–46.1%; P < .001). Importance of sexual health varied by sex, age, sexual activity status, and general self-rated health. For the 55% of men and 45% of women who reported sexual activity in the previous 30 days, satisfaction with sex life differed by sex, age, race/ethnicity (among men only), and health. Men and women in excellent health had significantly higher satisfaction than participants in fair or poor health. Women with hypertension reported significantly lower satisfaction (especially younger women), as did men with depression or anxiety (especially younger men). Conclusion In this large study of US adults’ ratings of the importance of sexual health and satisfaction with sex life, sexual health was a highly important aspect of quality of life for many participants, including participants in poor health. Moreover, participants in poorer health reported lower sexual satisfaction. Accordingly, sexual health should be a routine part of clinicians’ assessments of their patients. Health care systems that state a commitment to improving patients’ overall health must have resources in place to address sexual concerns. These resources should be available for all patients across the life span.

clinicaltrials.gov Identifier: NCT02462824.