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.

PURPOSE Current health literacy screening instruments for health care settings are either too long for routine use or available only in English. Our objective was to develop a quick and accurate screening test for limited literacy available in English and Spanish. METHODSWe administered candidate items for the new instrument and also the Test of Functional Health Literacy in Adults (TOFHLA) to English-speaking and Spanish-speaking primary care patients. We measured internal consistency with Cronbach's ␣ and assessed criterion validity by measuring correlations with TOFHLA scores. Using TOFLHA scores <75 to defi ne limited literacy, we plotted receiver-operating characteristics (ROC) curves and calculated likelihood ratios for cutoff scores on the new instrument. RESULTSThe fi nal instrument, the Newest Vital Sign (NVS), is a nutrition label that is accompanied by 6 questions and requires 3 minutes for administration. It is reliable (Cronbach ␣ >0.76 in English and 0.69 in Spanish) and correlates with the TOFHLA. Area under the ROC curve is 0.88 for English and 0.72 for Spanish versions. Patients with more than 4 correct responses are unlikely to have low literacy, whereas fewer than 4 correct answers indicate the possibility of limited literacy.CONCLUSION NVS is suitable for use as a quick screening test for limited literacy in primary health care settings. 1-3 Health literacy is the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. 4 It involves the ability to use and interpret text, documents, and numbers effectively-skills that might seem to be distinct but are highly correlated with one another. 1,[5][6][7] The IOM, AHRQ, and AMA reports all noted that large segments of the American population-as many as one half of all adults-lack the literacy skills needed to function adequately in a health care environment. They would not, for example, be able to reliably and consistently determine the proper dose of cold medicine for a child, nor would they be able to read and understand informed consent documents. 8,9 Individuals with limited literacy come from all segments of society, and most are white, native-born Americans. 10 Individuals with limited literacy have less knowledge about their health problems, [11][12][13][14][15][16] 27,28 which is the instrument most often used for literacy assessment in health care research. The TOFHLA is available in English and Spanish and has good psychometric characteristics, but the length of time required for administration of the TOFHLA (18 to 22 minutes for the full version and 7 to10 minutes for a short version) precludes its use in busy primary care settings. 29 The second test, the Rapid Estimate of Adult Literacy in Medicine (REALM), can be administered quickly (less than 3 minutes) but it, too, has limitations. In particular, the REALM is only available in English. 5,28 This report describes the validation of a new rapid literacy assessment instrume...

Low literacy is associated with several adverse health outcomes. Future research, using more rigorous methods, will better define these relationships and guide developers of new interventions.

Child and parent literacy seems associated with important health outcomes. Future research can help us understand under what circumstances this relationship is causal, how literacy and health outcomes are related in noncausal pathways, the relative importance of parent and child literacy, and what interventions effectively reduce health literacy-related disparities.

Background: Opioid misuse can complicate chronic pain management, and the non-medical use of opioids is a growing public health problem. The incidence and risk factors for opioid misuse in patients with chronic pain, however, have not been well characterized. We conducted a prospective cohort study to determine the one-year incidence and predictors of opioid misuse among patients enrolled in a chronic pain disease management program within an academic internal medicine practice.

One of the PROMIS (Patient-Reported Outcome Measurement Information System) network's primary goals is the development of a comprehensive item bank for patient-reported outcomes of chronic diseases. For its first set of item banks, PROMIS chose to focus on pain, fatigue, emotional distress, physical function, and social function. An essential step for the development of an item pool is the identification, evaluation, and revision of extant questionnaire items for the core item pool. In this work, we also describe the systematic process wherein items are classified for subsequent statistical processing by the PROMIS investigators. Six phases of item development are documented: identification of extant items, item classification and selection, item review and revision, focus group input on domain coverage, cognitive interviews with individual items, and final revision before field testing. Identification of items refers to the systematic search for existing items in currently available scales. Expert item review and revision was conducted by trained professionals who reviewed the wording of each item and revised as appropriate for conventions adopted by the PROMIS network. Focus groups were used to confirm domain definitions and to identify new areas of item development for future PROMIS item banks. Cognitive interviews were used to examine individual items. Items successfully screened through this process were sent to field testing and will be subjected to innovative scale construction procedures.

Poor numeracy skills were common in patients with diabetes. Low diabetes-related numeracy skills were associated with worse perceived self-efficacy, fewer self-management behaviors, and possibly poorer glycemic control.

The health literacy demands of the healthcare system often exceed the health literacy skills of Americans. This article reviews the development of the Health Literacy Universal Precautions (HLUP) Toolkit, commissioned by the Agency for Healthcare Research and Quality and designed to help primary care practices structure the delivery of care as if every patient may have limited health literacy. The development of the toolkit spanned 2 years and consisted of 3 major tasks: (1) developing individual tools (modules explaining how to use or implement a strategy to minimize the effects of low health literacy), using existing health literacy resources when possible, (2) testing individual tools in clinical practice and assembling them into a prototype toolkit, and (3) testing the prototype toolkit in clinical practice. Testing revealed that practices will use tools that are concise and actionable and are not perceived as being resource intensive. Conducting practice self-assessments and generating enthusiasm among staff were key elements for successful implementation. Implementing practice changes required more time than anticipated and some knowledge of quality improvement techniques. In sum, the HLUP Toolkit holds promise as a means of improving primary care for people with limited health literacy, but further testing is needed. KeywordsHealth literacy; Quality improvement * Corresponding author: Dr. Darren A. DeWalt, Division of General Internal Medicine, University of North Carolina, 5041 Old Clinic Building, CB#7110, Chapel Hill, NC 27599, dewaltd@med.unc.edu (D.A. DeWalt). Competing InterestsThe author(s) declare that they have no competing interests. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptThe complexity of the healthcare system makes it difficult for many Americans to receive the best possible care. More than one-third of U.S. adults have limited health literacy-the ability to understand and use health information to make decisions. 1 People with limited health literacy are less likely to engage in disease prevention behaviors, to know about their illness and medicines, and to manage and control a chronic disease. 2 Limited health literacy is associated with multiple adverse outcomes including rates of hospitalization and mortality. 2-4 Furthermore, the skills of patients, even those who have adequate health literacy skills, can decline when under the stress of illness or facing a new diagnosis.On the demand side, medical care is complex. Routine healthcare activities such as receiving instructions at the doctor's office, taking medication, preparing for a screening test, and choosing a treatment option require sophisticated skills. Health information is often presented in such a way that proficiency in literacy and numeracy is needed to make informed health decisions. Developing systems of care that do not require advanced health literacy skills could improve the delivery of safe, timely, efficient, effective, equitable, and patient-centered care. 5Pract...