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Objective. The aims of this study were to (1) evaluate the suitability of newly developed items for calibration into 2 item banks for stroke upper extremity (SUE) and stroke lower extremity (SLE) physical function (PF) patient-reported outcome measures (PROMs) and to (2) assess score reliability and validity and PROM administration efficiency based on computerized adaptive testing (CAT). Methods. A retrospective longitudinal study involving patients poststroke who were treated in outpatient rehabilitation clinics and responded to 28 and 25 region-specific candidate items addressing tasks related to upper or lower extremity PF, respectively, was conducted. Item response theory (IRT) model assumptions of unidimensionality, local independence, item fit, and presence of differential item functioning were evaluated. CAT-generated scores were assessed for reliability, validity, and administration efficiency, and 10-item short forms were assessed for reliability. Results. Cohorts consisted of 2017 patients with stroke involving the upper extremity and 2107 patients with stroke involving the lower extremity (mean age [SD]: SUE = 62 [14] and SLE = 63 [14]; range = 14-89). Two solutions (SUE: 28-item; SLE: 24-item) supported unidimensionality and fit to the IRT model, with reliability estimates >0.93 for all administration modes. No items demonstrated differential item functioning. Scores discriminated among multiple patient groups in clinically logical ways, with better outcomes observed for patients who were younger, were male, had less chronicity, and had fewer comorbidities. The SUE and SLE, respectively, had 1 and 0.3% floor effects and 4.3 and 1.1% ceiling effects. Change score effect sizes were 0.5 (SUE) and 0.6 (SLE). Simulated CAT scores required an average of 6 (SUE) and 5.6 (SLE) items (median = 5). Conclusion. The stroke upper extremity and stroke lower extremity PROM scores were reliable, valid, and efficient and had moderate change effect sizes for assessing PF as perceived by patients poststroke with upper and lower extremity impairments. Scores had negligible floor and acceptable ceiling effects. Based on these results, the stroke PROMs are suitable for research and routine clinical practice. Impact. As IRT-based measures, these PROMs support clinical practice guideline recommendations for the use of outcome measures in neurologic physical therapy and the administration of condition-specific functional questions with low response burden for patients. The 10-item short forms offer a feasible alternative administration mode when CAT administration is not available. Keywords: Item Response Theory, Lower Extremity, Patient-Reported Outcome Measures, Physical Function, Stroke, Upper Extremity, Introduction On average, every 40 seconds, someone in the USA has a stroke. (1) Reliable and valid measures of physical function (PF) can provide valuable information for poststroke management. Patient-reported [...]

Objective. The main aims of this study were: (1) to create a patient-reported outcome measure (PROM) item bank for measuring the impact of lower quadrant edema (LQE) on physical function using item response theory and (2) to assess reliability, validity, and administration efficiency of LQE PROM scores based on computerized adaptive test (CAT) and the reliability of a 10-item short form (SF). Methods. This retrospective study included data from patients treated in outpatient rehabilitation clinics for lower quadrant edema who responded to all 30 candidate items at intake. Item response theory model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning (DIF) were evaluated. LQE-CAT-generated scores were assessed for reliability, validity, and administration efficiency. LQE-SF-generated scores were assessed for reliability. Results. The total cohort included 4894 patients (mean [SD] age = 65 [14] years; range = 14-89 years). A set of 20 items was selected for the item bank based on support for its unidimensionality and fit to the item response theory model, with reliability estimates greater than 0.92 for CAT and SF administration modes. No items demonstrated DIF with respect to tested variables. After controlling for scores at intake, scores discriminated among multiple patient groups in clinically logical ways with better outcomes observed for patients who were younger with less chronic symptoms and fewer comorbidities. Scores were responsive to change but the effect size was small (0.4). There were negligible floor and ceiling effects. CAT administration of the item bank required an average of 6.1 items (median = 5). Scores correlated highly with full-bank scores (Pearson correlation coefficient = 0.98). Conclusion. Scores on the LQE PROM were reliable, valid, and efficient for assessing perceived physical function of patients with lower quadrant edema. The LQE, CAT, and SF are suitable for research and routine clinical care. Reasons for the small effect size for change scores should be studied. Impact. The newly developed LQE PROM was reliable and valid and offered efficient administration modes for assessing perceived physical function of patients with LQE, both for research and routine clinical care in busy outpatient rehabilitation settings. As an item response theory-based measure, the LQE PROM allows administration of condition-specific functional questions with low response burden for patients. The 10-item LQE-SF offers a feasible alternative administration mode when CAT administration is not available. This study supports a transition to PROMs that are based on modern measurement approaches to achieve the combined benefits of high accuracy and efficiency. Keywords: Computerized Adaptive Testing, Item Response Theory, Lower Quadrant Edema, Lymphedema, Patient-Reported Outcome Measures, Physical Function, Introduction Chronic lower quadrant edema (LQE), defined as swelling that persists beyond 3 months, is a progressive, incurable, physically disfiguring, and disabling condition. (1) Edema is caused by increased interstitial [...]

Objective. The main aims of this study were to (1) create a patient-reported outcome measure (PROM) item bank for measuring the impact of upper quadrant edema (UQE) on physical function by calibrating responses to newly developed items; and (2) assess reliability, validity, and administration efficiency of scores based on computerized adaptive test (CAT) and 10-item short-form (SF) administration modes. Methods. This was a retrospective study including data from patients treated in outpatient rehabilitation clinics for UQE that responded to all 27 candidate items at intake. Item response theory model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning were evaluated. UQE-CAT--and UQE-SF--generated scores were assessed for reliability, validity, and administration efficiency. Results. The total cohort included 3486 patients (mean [SD] age = 61 [13] years; range = 14-89 years). After removing 2 items, a 25-item solution was supported for its unidimensionality and fit to the item response theory model with reliability estimates of more than 0.93 for scores based on both CAT and SF administration modes. No items demonstrated differential item functioning. Scores discriminated among multiple patient groups in clinically logical ways and were moderately responsive to change with negligible floor and acceptable ceiling effects. CAT scores were generated using an average of 5.6 items (median= 5). Conclusion. Scores on the UQE PROM were reliable, valid, and efficient for assessing perceived physical function of patients with upper quadrant edema; thus, the measure is suitable for research and routine clinical administration. Impact. The newly developed UQE PROM is reliable and valid and offers efficient administration modes for assessing perceived physical function of patients with UQE caused by lymphatic and venous disorders, both for research and routine clinical care in busy outpatient rehabilitation settings. As an item response theory--based measure, the UQE PROM allows administration of condition-specific functional questions with low response burden for patients. This study supports a transition to PROMs that are based on modern measurement approaches to achieve high accuracy and efficiency. Keywords: Computerized Adaptive Testing, Edema, Item Response Theory, Lymphedema, Patient-Reported Outcome Measures, Physical Function, Introduction Patient-reported outcome measures (PROMs) can provide valuable information for individuals with lymphatic and venous disorders that cause upper quadrant edema (UQE), translating the patient's experience of the edema load [...]

Objective. To evaluate rehabilitation inpatients' willingness and ability to complete patient-reported outcomes (PROs) and the burden of completion on patients and staff. Data Sources/Study Setting. Two inpatient rehabilitation facilities. Study Design. Patients with neurological disorders were assigned randomly to receive a nominal monetary incentive during or 1 month after the stay. Data Collection. Patients responded using a tablet computer or paper. Principal Findings. Of the 1,055 admissions, 74 percent were eligible, and 51 percent of eligible patients completed the survey. Most answered without assistance. A majority completed the survey 1 month after discharge; incentive timing was unrelated to post-discharge completion. Half of the 285 follow-up respondents required at least two reminder calls. Conclusions. Collection of PROs from rehabilitation patients is feasible. Results inform policy makers regarding feasibility of PRO data in evaluating rehabilitation quality. Key Words. Quality of care/patient safety (measurement), quality improvement/report cards (interventions), rehabilitation services, patient assessment/satisfaction, disability, Health care quality in the United States varies widely (Agency for Healthcare Research and Quality [AHRQ] 2010; Fisher et al. 2003; Institute of Medicine 1999, 2001; McGlynn et al. 2003; [...]

•The term pain catastrophizing is widespread in clinical and public pain forums.•About 3,000 patients provided their perspective on the term pain catastrophizing.•For an open-ended item, 1/3 said the term was problematic or stigmatizing.•There was an absence of unprompted assessment of the term for 2/3 of the sample.•12% reported stigmatizing experiences from the term being applied to them.

Background. Computerized adaptive tests (CATs) promise efficient outcomes data collection with little loss of measurement precision. The shoulder CAT has not been assessed for administrative efficiency, nor have prospective studies been completed to evaluate the sensitivity to change or the responsiveness of CAT-based functional status (CAT-FS) measures. Objective. The purpose of this study was to evaluate the efficiency and responsiveness of the shoulder CAT. Design. This was a secondary analysis of prospectively collected data. Methods. Data were analyzed from patients with shoulder impairments who received outpatient rehabilitation in 518 clinics in 30 US states. Over the testing time, 30,987 patients completed the shoulder CAT at intake, and of these, 13,805 completed the CAT at discharge (45% completion rate). The efficiency of routine CAT administration was evaluated, and the sensitivity to change and responsiveness of CAT-FS measures were assessed. Results. On average, patients took about 1.5 minutes (SD Limitations. Because this study was a secondary analysis, the results may have been affected by patient selection bias. Future studies would benefit from more complete data. Conclusions. The results indicate the shoulder CAT was efficient and support the precision, sensitivity, and responsiveness of CAT-FS measures., Measurement of patient-reported outcomes in health care is evolving, with patients and clinicians benefiting from the administrative efficiency and measure precision of computerized adaptive tests (CATs). (1) A CAT is [...]

Background. Screening people for elevated levels of fear-avoidance beliefs is uncommon, but elevated levels of fear could worsen outcomes. Developing short screening tools might reduce the data collection burden and facilitate screening, which could prompt further testing or management strategy modifications to improve outcomes. Objective. The purpose of this study was to develop efficient yet accurate screening methods for identifying elevated levels of fear-avoidance beliefs regarding work or physical activities in people receiving outpatient rehabilitation. Design. A secondary analysis of data collected prospectively from people with a variety of common neuromusculoskeletal diagnoses was conducted. Methods. Intake Fear-Avoidance Beliefs Questionnaire (FABQ) data were collected from 17,804 people who had common neuromusculoskeletal conditions and were receiving outpatient rehabilitation in 121 clinics in 26 states (in the United States). Item response theory (IRT) methods were used to analyze the FABQ data, with particular emphasis on differential item functioning among clinically logical groups of subjects, and to identify screening items. The accuracy of screening items for identifying subjects with elevated levels of fear was assessed with receiver operating characteristic analyses. Results. Three items for fear of physical activities and 10 items for fear of work activities represented unidimensional scales with adequate IRT model fit. Differential item functioning was negligible for variables known to affect functional status outcomes: sex, age, symptom acuity, surgical history, pain intensity, condition severity, and impairment. Items that provided maximum information at the median for the FABQ scales were selected as screening items to dichotomize subjects by high versus low levels of fear. The accuracy of the screening items was supported for both scales. Limitations. This study represents a retrospective analysis, which should be replicated using prospective designs. Future prospective studies should assess the reliability and validity of using one FABQ item to screen people for high levels of fear-avoidance beliefs. Conclusions. The lack of differential item functioning in the FABQ scales in the sample tested in this study suggested that FABQ screening could be useful in routine clinical practice and allowed the development of single-item screening for fear-avoidance beliefs that accurately identified subjects with elevated levels of fear. Because screening was accurate and efficient, single IRT-based FABQ screening items are recommended to facilitate improved evaluation and care of heterogeneous populations of people receiving outpatient rehabilitation., Clinicians and researchers have recognized the role that psychosocial factors play in the development of chronic disability in people with low back pain. (1-3) Among the psychosocial risk factors are [...]

Background. The use of item response theory (IRT) to measure self-reported outcomes has burgeoned in recent years. Perhaps the most important application of IRT is computer-adaptive testing (CAT), a measurement approach in which the selection of items is tailored for each respondent. Objective. To provide an introduction to the use of CAT in the measurement of health outcomes, describe several IRT models that can be used as the basis of CAT, and discuss practical issues associated with the use of adaptive scaling in research settings. Principal Points. The development of a CAT requires several steps that are not required in the development of a traditional measure including identification of "starting" and "stopping" rules. CAT's most attractive advantage is its efficiency. Greater measurement precision can be achieved with fewer items. Disadvantages of CAT include the high cost and level of technical expertise required to develop a CAT. Conclusions. Researchers, clinicians, and patients benefit from the availability of psychometrically rigorous measures that are not burdensome. CAT outcome measures hold substantial promise in this regard, but their development is not without challenges. Key Words. Measurement, quality of life, psychometrics, reliability, Measures of patient-centered outcomes are critical to health services research since they supply information on which clinical and health policy decisions may be made. Patient-level data is used to track [...]

Objective. The purpose of this paper is to introduce researchers to the measurement and subsequent analysis considerations involved when using externally rated data. We will define and describe two categories of externally rated data, recommend methodological approaches for analyzing and interpreting data in these two categories, and explore factors affecting agreement between self-rated and externally rated reports. We conclude with a discussion of needs for future research. Data Sources/Study Setting. Data sources for this paper are previous published studies and reviews comparing self rated with externally rated data. Study Design/Data Collection/Extraction Methods. This is a psychometric conceptual paper. Principal Findings. We define two types of externally rated data: proxy data and other rated data. Proxy data refer to those collected from someone who speaks for a patient who cannot, will not, or is unavailable to speak for him or herself, whereas we use the term other rater data to refer to situations in which the researcher collects ratings from a person other than the patient to gain multiple perspectives on the assessed construct. These two types of data differ in the way the measurement model is defined, the definition of the gold standard against which the measurements are validated, the analysis strategies appropriately used, and how the analyses are interpreted. There are many factors affecting the discrepancies between self- and external ratings, including characteristics of the patient, the proxy, and of the rated construct. Several psychological theories can be helpful in predicting such discrepancies. Conclusions. Externally rated data have an important place in health services re search, but use of such data requires careful consideration of the nature of the data and how it will be analyzed and interpreted. Key Words. Validity, proxy, self report, Health services researchers often need to collect information about patients from external raters (as opposed to internally referenced self-reports) because a patient is sick/impaired/unavailable/deceased or because another perspective on the [...]

Objective. To examine potential sources of errors at each step of the described inpatient International Classification of Diseases (ICD) coding process. Data Sources/Study Setting. The use of disease codes from the ICD has expanded from classifying morbidity and mortality information for statistical purposes to diverse sets of applications in research, health care policy, and health care finance. By describing a brief history of ICD coding, detailing the process for assigning codes, identifying where errors can be introduced into the process, and reviewing methods for examining code accuracy, we help code users more systematically evaluate code accuracy for their particular applications. Study Design/Methods. We summarize the inpatient ICD diagnostic coding process from patient admission to diagnostic code assignment. We examine potential sources of errors at each step and offer code users a tool for systematically evaluating code accuracy. Principle Findings. Main error sources along the "patient trajectory" include amount and quality of information at admission, communication among patients and providers, the clinician's knowledge and experience with the illness, and the clinician's attention to detail. Main error sources along the "paper trail" include variance in the electronic and written records, coder training and experience, facility quality-control efforts, and unintentional and intentional coder errors, such as misspecification, unbundling, and upcoding. Conclusions. By clearly specifying the code assignment process and heightening their awareness of potential error sources, code users can better evaluate the applicability and limitations of codes for their particular situations. ICD codes can then be used in the most appropriate ways. Key Words. ICD codes, accuracy, error sources, Nosology (the systematic classification of diseases) has always fascinated the sick and their would-be healers. Western societies developed an interest in nosology in the seventeenth and eighteenth centuries when they [...]

Background and Purpose. Shoulder scales are often used to evaluate treatment efficacy, yet little is known about the psychometric properties of these scales. Only one scale has undergone psychometric scrutiny: the Shoulder Pain and Disability Index (SPADI). This study compared 2 shoulder measures--the University of California-Los Angeles (UCLA) Shoulder Scale and the Simple Shoulder Test (SST)--with the SPADI. Subjects. One hundred ninety-two patients with shoulder disorders were recruited from one physician's office to complete the self-report sections of the 3 scales. Methods. Cronbach alpha values and standard errors of measurement (SEM) were calculated for each of the multi-item subscales. Validity was examined through calculation of correlation coefficients among the 3 scales. Factor analysis was completed to assess the underlying constructs of the SPADI and the SST. Results. Cronbach alpha values ranged from .85 to .95. The SEM values for the multi-item scales ranged from 4.75 to 11.65. Evidence for validity to reflect function was indicated by the correlation between the SST and the SPADI disability subscale. The factor analysis of the SPADI revealed loading on 1 factor, whereas the SST loaded on 2 factors. Conclusion and Discussion. All scales demonstrated good internal consistency, suggesting that all items for each scale measure the same construct. However, the SEMs for all scales were high. Factor loading was inconsistent, suggesting that patients may not distinguish between pain and function. [Roddey TS, Olson SL, Cook KF, et al. Comparison of the University of California-Los Angeles Shoulder Scale and the Simple Shoulder Test with the Shoulder Pain and Disability Index: single-administration reliability and validity. Phys Ther. 2000;80:759-768.] Key Words: Outcome assessment (health care), Psychometrics, Shoulder, Shoulder joint., The Institute of Medicine's (IOM) model of disability has 3 components: risk factors, the disablement process, and quality of life.[1] The disablement process consists of pathology (cellular/tissue level), impairment (organ [...]

Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed non-specific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. Therefore, NIH Pain Consortium charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimum dataset to describe research participants (drawing heavily on the PROMIS methodology); reporting 'responder analyses' in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. We expect that the RTF recommendations will become a dynamic document and undergo continual improvement. Perspective: A task force was convened by the NIH Pain Consortium with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimum dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. Key words: Low back pain, chronic low back pain, research standards, minimum dataset, NIH Task Force., This article is available online only at: [...]

In 2009, the Army Pain Management Task Force was chartered. On the basis of their findings, the Department of Defense recommended a comprehensive pain management strategy that included development of a standardized pain assessment system that would collect patient-reported outcomes data to inform the patient-provider clinical encounter. The result was the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). The purpose of this study was to assess the validity and response burden of the patient-reported outcome measures in PASTOR.

•Evidence is lacking supporting the use of any single PRO fatigue measure across all settings in persons with MS.•Observational studies were performed across US and UK MS populations.•Relative validity of PROMIS Fatigue (MS) 8a score in comparison to the MFIS and FSS scores was evaluated.•Stronger psychometric performance was observed for the PROMIS Fatigue (MS) 8a scores compared to scores from legacy fatigue measures.

•An improved and comprehensive technique for measuring/assessing self-reported physical function is needed in MS.•We have developed a new PROMIS short form for assessing physical function in MS.•The new short form demonstrated validity and reliability across US and UK MS populations.•A preliminary minimal important difference estimate and score interpretation guidance are provided.

Prospective longitudinal cohort study.

The construction and evaluation of item banks to measure unidimensional constructs of health-related quality of life (HRQOL) is a fundamental objective of the Patient-Reported Outcomes Measurement Information System (PROMIS) project.

The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years.

This study was conducted to evaluate the relationship among patient outcome expectancies, perceived shoulder function changes, and perceptions of expectancy fulfillment.

The objective of this study was to evaluate the convergent validity of 3 types of utility measures standard gamble, time tradeoff, and rating scale.

•Current questionnaires used to measure fatigue in patients with MS exhibit varied robustness in psychometric properties.•We evaluated the PROMIS Fatigue (MS) 8a as a measure of fatigue severity in MS.•The instrument demonstrated strong validity, test-retest reliability and responsiveness.•The psychometric properties of the PROMIS Fatigue (MS) 8a as reported in the current study are generalizable to patients with MS not requiring a scooter or wheelchair for mobility.•Our data extend evidence supporting this fatigue measure across MS populations.

Utility techniques are the most commonly used means to assess patient preferences for health outcomes. However, whether utility techniques produce valid measures of preference has been difficult to determine in the absence of a gold standard.

Comparison of the University of California (Los Angeles) shoulder scale and the simple shulder test with shoulder pain and disability index: Single‐administration reliability and validity. (Texas Woman's University, Houston, TX) Phys Ther.2000;80:759–768.