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Study designThis is a focused review article.ObjectivesThis review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified.MethodsThe methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review.ResultsCOAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered.ConclusionsWith an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA.SponsorsCraig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

This study introduces a special series on validity studies of the Cognition Battery (CB) from the U.S. National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function (NIHTB) (Gershon, Wagster et al., 2013) in an adult sample. This first study in the series describes the sample, each of the seven instruments in the NIHTB-CB briefly, and the general approach to data analysis. Data are provided on test-retest reliability and practice effects, and raw scores (mean, standard deviation, range) are presented for each instrument and the gold standard instruments used to measure construct validity. Accompanying papers provide details on each instrument, including information about instrument development, psychometric properties, age and education effects on performance, and convergent and discriminant construct validity. One study in the series is devoted to a factor analysis of the NIHTB-CB in adults and another describes the psychometric properties of three composite scores derived from the individual measures representing fluid and crystallized abilities and their combination. The NIHTB-CB is designed to provide a brief, comprehensive, common set of measures to allow comparisons among disparate studies and to improve scientific communication.

The List Sorting Working Memory Test was designed to assess working memory (WM) as part of the NIH Toolbox Cognition Battery. List Sorting is a sequencing task requiring children and adults to sort and sequence stimuli that are presented visually and auditorily. Validation data are presented for 268 participants ages 20 to 85 years. A subset of participants (N=89) was retested 7 to 21 days later. As expected, the List Sorting Test had moderately high correlations with other measures of working memory and executive functioning (convergent validity) but a low correlation with a test of receptive vocabulary (discriminant validity). Furthermore, List Sorting demonstrates expected changes over the age span and has excellent test-retest reliability. Collectively, these results provide initial support for the construct validity of the List Sorting Working Memory Measure as a measure of working memory. However, the relationship between the List Sorting Test and general executive function has yet to be determined.

This chapter focuses on the NIH Toolbox List Sorting Working Memory Test, which was developed to assess processing speed within the NIH Toolbox Cognition Battery (CB). This test is a sequencing task requiring children and adults to process stimuli (presented both visually and auditorily) and sequence the stimuli according to size. We describe the development of the NIH Toolbox List Sorting Working Memory Test, highlighting its utility in children. We examine descriptive data, test-retest reliability, and convergent and discriminant validity. Results indicated that List Sorting performance was positively correlated with age indicating that performance on the task improved throughout childhood and early adolescence. Further, test-retest reliability coefficients were high and there was support for both convergent and discriminant validity. These data suggest that the NIH Toolbox List Sorting Working Memory Test is reliable and shows evidence of construct validity.

This monograph presents the pediatric portion of the National Institutes of Health (NIH) Toolbox Cognition Battery (CB) of the NIH Toolbox for the Assessment of Neurological and Behavioral Function. The NIH Toolbox is an initiative of the Neuroscience Blueprint, a collaborative framework through which 16 NIH Institutes, Centers, and Offices jointly support neuroscience-related research, to accelerate discoveries and reduce the burden of nervous system disorders. The CB is one of four modules that measure cognitive, emotional, sensory, and motor health across the lifespan. The CB is unique in its continuity across childhood, adolescence, early adulthood, and old age, and in order to help create a common currency among disparate studies, it is also available at low cost to researchers for use in large-scale longitudinal and epidemiologic studies. This chapter describes the evolution of the CB; methods for selecting cognitive subdomains and instruments; the rationale for test design; and a validation study in children and adolescents, ages 3-15 years. Subsequent chapters feature detailed discussions of each test measure and its psychometric properties (Chapters 2-6), the factor structure of the test battery (Chapter 7), the effects of age and education on composite test scores (Chapter 8), and a final summary and discussion (Chapter 9). As the chapters in this monograph demonstrate, the CB has excellent psychometric properties, and the validation study provided evidence for the increasing differentiation of cognitive abilities with age.

A rap contest methodology for smoking prevention was tested with sixth and seven grade students in a predominantly minority public school district. Contests were held after initial assemblies in which students heard anti-smoking rap messages from same-age and older peers on audio and video tape. Pretesting and posttesting (N = 268) indicated high preference ratings for most aspects of the intervention. Analyses of variance revealed no differences across races on any of the dependent measures. However, smaller assemblies were more effective than larger ones in enhancing attitudes against smoking and obtaining more positive contest evaluations and predictions about smoking behavior. A rap contest method therefore may be effective against the initiation of smoking by disadvantaged children in sixth and seventh grades because it is highly acceptable and perceived as culturally relevant. This effectiveness may be more domonstrable in single classrooms rather than larger assemblies. (J Sch Health.1992;62(8):377-380), School-based interventions to prevent smoking have become well-established.[1] Prior to 1978, smoking prevention programs emphasized 'scare tactics,' depicting health consequences of smoking.[2] More contemporary curricula focused on skills to resist [...]

Purpose: The Patient-Reported Outcomes Measurement Information System (PROMIS ®) provides adult and pediatric self-report measures of health-related quality of life designed for use across medical conditions and the general population. The purpose of this study was to examine the feasibility and validity of the PROMIS ® Pediatric Short Form and computer-adaptive test (CAT) mobility measures in children with cerebral palsy (CP). Methods: Eighty-two children with CP completed self-report (PROMIS ® Mobility Short Form, PROMIS ® Mobility CAT, Pediatric Quality of Life Inventory™) and performance-based assessments of mobility (Timed Up and Go, Gross Motor Function Measure). Parents provided three proxy reports of child mobility (Pediatric Outcomes Data Collection Instrument, Functional Assessment Questionnaire, Shriners Hospitals for Children CP-CAT). Validity of PROMIS ® instruments was examined through correlations with other measures and “known groups” analyses determined by Gross Motor Function Classification System (GMFCS). Results: On average, the PROMIS ® CAT required less than seven items and 2 minutes to administer. Both PROMIS ® measures showed moderate to high correlations with child- and parent-proxy report of child mobility; correlations with performance-based measure were small for the PROMIS ® Short Form and non-significant for the PROMIS ® CAT. All measures except for the PROMIS ® CAT were able to distinguish between GMFCS categories. Conclusions: Results support the convergent and discriminant validity of the pediatric PROMIS ® Mobility Short Form in children with CP. The PROMIS ® Mobility CAT correlates well with child report and parent report of mobility but not with performance-based measures and does not differentiate between known mobility groups. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network. PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making. The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context. IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed. [ABSTRACT FROM AUTHOR]

The importance of activities and community participation for persons with spinal cord injury (SCI) has been recognized for decades and yet theoretical and empirical advances have been limited. This report summarizes the recommendations for researchers on the topic of measuring activity and participation among persons with SCI formulated by the Spinal Cord Injury workgroup at the State-of-the-Art Conference on Outcome Measures in Rehabilitation held in January 2010. Activity and participation were defined as independent constructs ideally measured in reference to personal values and environmental influences. Measures of activity, participation, and factors influencing activity and participation are reviewed and critiqued. Gaps in available measures are described, measures in development are discussed, and suggestions for future research are made. [ABSTRACT FROM AUTHOR]

Background: People with disabilities, who face multiple barriers to care, experience health disparities, yet few studies have measured health literacy in this population., Objective: This study evaluated functional literacy, health literacy, fluid cognitive function, and self-reported health in people who live in community dwellings with spinal cord injury, stroke, or traumatic brain injury., Methods: Participants with a traumatic spinal cord injury, stroke, or traumatic brain injury, one-year postinjury, and age 18 to 85 years, completed a battery of instruments at three medical centers in the Midwestern U.S.: functional literacy (word recognition, vocabulary knowledge), health literacy (comprehension of prose, document, and quantitative health information), fluid cognitive function (memory, executive function, and processing speed), and patient-reported outcomes (mobility, fatigue, sadness, anxiety, social function, and overall health)., Key Results: There were strong correlations between functional literacy, health literacy, and fluid cognitive function. After adjustment for sociodemographic and clinical characteristics, higher health literacy was associated with better mobility, less anxiety, and better overall health; higher functional literacy was associated with less anxiety and better overall health; and higher fluid cognitive function was associated with better mobility, less sadness, better social function, and better overall health., Conclusions: To effectively address limited health literacy among people with spinal cord injury, stroke, and traumatic brain injury, and ensure that they are able to be informed partners in their health care, intervention is required at the level of patients, providers, and health care delivery systems. A special consideration is to ensure that health information is both well-targeted to people's health literacy levels and accessible for people with a range of physical, cognitive, and sensory limitations. The multimedia self-administered health literacy measure used in this study could be useful to rehabilitation providers and designers of health information and interfaces. [ Health Literacy Research and Practice. 2017;1(2):e71-e85.] ., Plain Language Summary: Health literacy represents people's abilities to obtain, understand, and use health information to make informed decisions about their health and health care. People with disabilities face physical, attitudinal, economic, and structural barriers to care. Consideration of health literacy in rehabilitation practice can enhance the effectiveness of the patient-clinician relationship and help address the needs of this population.