Background

About 70% of Latinos, 5 years old or older, in the United States speak Spanish at home. Measurement equivalence of the PROMIS^® pain interference (PI) item bank by language of administration (English versus Spanish) has not been evaluated.

Methods

A sample of 527 adult Spanish-speaking Latinos completed the Spanish version of the 41-item PROMIS^® pain interference item bank. We evaluate dimensionality, monotonicity and local independence of the Spanish-language items. Then we evaluate differential item functioning (DIF) using ordinal logistic regression with item response theory scores estimated from DIF-free "anchor" items.

Results

One of the 41 items in the Spanish version of the PROMIS^® PI item bank was identified as having significant uniform DIF.

Conclusions

English- and Spanish-speaking subjects with the same level of pain interference responded differently to 1 of the 41 items in the PROMIS^® PI item bank. This item was not retained due to proprietary issues. The original English language item parameters can be used when estimating PROMIS^® PI scores.

Background

Depression and physical function are particularly important health domains for the elderly. The Geriatric Depression Scale (GDS) and the Patient-Reported Outcomes Measurement Information System (PROMIS^®) physical function item bank are two surveys commonly used to measure these domains. It is unclear if these two instruments adequately measure these aspects of health in minority elderly.

Objective

The aim of this study was to estimate the readability of the GDS and PROMIS^® physical function items and to assess their comprehensibility using a sample of African American and Latino elderly.

Methods

Readability was estimated using the Flesch-Kincaid and Flesch Reading Ease (FRE) formulae for English versions, and a Spanish adaptation of the FRE formula for the Spanish versions. Comprehension of the GDS and PROMIS^® items by minority elderly was evaluated with 30 cognitive interviews.

Results

Readability estimates of a number of items in English and Spanish of the GDS and PROMIS^® physical functioning items exceed the U.S. recommended 5th-grade threshold for vulnerable populations, or were rated as 'fairly difficult', 'difficult', or 'very difficult' to read. Cognitive interviews revealed that many participants felt that more than the two (yes/no) GDS response options were needed to answer the questions. Wording of several PROMIS^® items was considered confusing, and interpreting responses was problematic because they were based on using physical aids.

Conclusions

Problems with item wording and response options of the GDS and PROMIS^® physical function items may reduce reliability and validity of measurement when used with minority elderly.

Purpose

To assess the equivalence of self-reports of physical functioning between pediatric respondents to the English- and Spanish-language patient-reported outcomes measurement information system (PROMIS^®) physical functioning item banks.

Methods

The PROMIS pediatric physical functioning item banks include 29 upper extremity items and 23 mobility items. A sample of 5091 children and adolescents (mean age = 12 years, range 8-17; 49% male) completed the English-language version of the items. A sample of 605 children and adolescents (mean age = 12 years, range 8-17; 55% male; 96% Hispanic) completed the Spanish-language version of the items.

Results

We found language (English versus Spanish) differential item functioning (DIF) for 4 upper extremity items and 7 mobility items. Product-moment correlations between estimated upper extremity and mobility scores using the English versus the equated Spanish item parameters for Spanish-language respondents were 0.98 and 0.99, respectively. After excluding cases with significant person misfit, we found DIF for the same 4 upper extremity items that had DIF in the full sample and for 12 mobility items (including the same 7 mobility items that had DIF in the full sample). The identification of DIF items between English- and Spanish-language respondents was affected slightly by excluding respondents displaying person misfit.

Conclusions

The results of this study provide support for measurement equivalence of self-reports of physical functioning by children and adolescents who completed the English- and Spanish-language surveys. Future analyses are needed to replicate the results of this study in other samples.

To estimate readability of seven commonly used health-related quality of life instruments: SF-36, HUI, EQ-5D, QWB-SA, HALex, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the NEI-VFQ-25. The Flesch–Kincaid (F–K) and Flesch Reading Ease (FRE) formulae were used to estimate readability for every item in each measure. The percentage of items that require more than 5 years of formal schooling according to F–K was 50 for the EQ-5D, 53 for the SF-36, 80 for the VFQ-25, 85 for the QWB-SA, 100 for the HUI, HALex, and the MLHFQ. The percentage of items deemed harder than “easy” according to FRE was 50 for the SF-36, 67 for the EQ-5D, 79 for the QWB-SA, 80 for the VFQ-25, 100 for the HUI, HALex, and the MLHFQ. All seven surveys have a substantial number of items with high readability levels that may not be appropriate for the general population.

Purpose

To evaluate the equivalence of the PROMIS(®) physical functioning item bank by language of administration (English versus Spanish).

Methods

The PROMIS(®) wave 1 English-language physical functioning bank consists of 124 items, and 114 of these were translated into Spanish.

Analysis

Item frequencies, means and standard deviations, item-scale correlations, and internal consistency reliability were calculated. The IRT assumption of unidimensionality was evaluated by fitting a single-factor confirmatory factor analytic model. IRT threshold and discrimination parameters were estimated using Samejima's Graded Response Model. DIF by language of administration was evaluated.

Results

Item means ranged from 2.53 (SD = 1.36) to 4.62 (SD = 0.82). Coefficient alpha was 0.99, and item-rest correlations ranged from 0.41 to 0.89. A one-factor model fits the data well (CFI = 0.971, TLI = 0.970, and RMSEA = 0.052). The slope parameters ranged from 0.45 ("Are you able to run 10 miles?") to 4.50 ("Are you able to put on a shirt or blouse?"). The threshold parameters ranged from -1.92 ("How much do physical health problems now limit your usual physical activities (such as walking or climbing stairs)?") to 6.06 ("Are you able to run 10 miles?"). Fifty of the 114 items were flagged for DIF based on an R(2) of 0.02 or above criterion. The expected total score was higher for Spanish- than English-language respondents.

Conclusions

English- and Spanish-speaking subjects with the same level of underlying physical function responded differently to 50 of 114 items. This study has important implications in the study of physical functioning among diverse populations.

Objectives

The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a standardized set of patient-reported outcomes (PROs) that cover physical, mental, and social health. The aim of this study was to develop the NIH PROMIS gastrointestinal (GI) symptom measures.

Methods

We first conducted a systematic literature review to develop a broad conceptual model of GI symptoms. We complemented the review with 12 focus groups including 102 GI patients. We developed PROMIS items based on the literature and input from the focus groups followed by cognitive debriefing in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and a census-based US general population (GP) control sample. We created scales based on confirmatory factor analyses and item response theory modeling, and evaluated the scales for reliability and validity.

Results

A total of 102 items were developed and administered to 865 patients with GI conditions and 1,177 GP participants. Factor analyses provided support for eight scales: gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). The scales correlated significantly with both generic and disease-targeted legacy instruments, and demonstrate evidence of reliability.

Conclusions

Using the NIH PROMIS framework, we developed eight GI symptom scales that can now be used for clinical care and research across the full range of GI disorders.

Purpose

To develop a vision-targeted health-related quality-of-life instrument for patients with glaucoma who are candidates for minimally invasive glaucoma surgery (MIGS).

Design

Development of a health-related quality-of-life instrument.

Participants

Twelve practicing ophthalmologists and 41 glaucoma patients.

Methods

A questionnaire was constructed to assess functional limitations, vision-related symptoms, aesthetics, psychosocial issues, and surgical satisfaction for MIGS candidates. Questions were drafted after a review of the literature and subsequently refined based upon input from 1 physician and 4 patient focus groups. Nineteen cognitive interviews were used to ensure that questions were understandable to respondents.

Results

The focus group identified the following key issues and concerns as being important to glaucoma patients: functional limitations (eg, driving), bodily discomfort (eg, stinging from drops), changes in appearance (eg, drooping eyelid), and psychosocial concerns (eg, mental burden associated with a diagnosis of glaucoma, financial burden of treatment). Cognitive interviews resulted in the following improvements to the questionnaire: changes in wording to clarify lighting conditions, and additional questions addressing psychosocial issues, such as job loss, severity of disease, and perception of MIGS.

Conclusions

A patient-reported outcomes instrument, the Glaucoma Outcomes Survey, was developed to evaluate MIGS for patients with mild to moderate glaucoma. Next steps include electronic administration to patients selected from the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) registry. An electronic patient-reported outcomes platform will be used to administer the questionnaire before and after MIGS. The questionnaire will improve understanding of how surgical interventions such as MIGS impact vision-targeted health-related quality-of-life in glaucoma patients.

Purpose

To develop a vision-targeted health-related quality of life (HRQOL) measure for the NIH Toolbox for the Assessment of Neurological and Behavioral Function.

Methods

We conducted a review of existing vision-targeted HRQOL surveys and identified color vision, low luminance vision, distance vision, general vision, near vision, ocular symptoms, psychosocial well-being, and role performance domains. Items in existing survey instruments were sorted into these domains. We selected non-redundant items and revised them to improve clarity and to limit the number of different response options. We conducted 10 cognitive interviews to evaluate the items. Finally, we revised the items and administered them to 819 individuals to calibrate the items and estimate the measure's reliability and validity.

Results

The field test provided support for the 53-item vision-targeted HRQOL measure encompassing 6 domains: color vision, distance vision, near vision, ocular symptoms, psychosocial well-being, and role performance. The domain scores had high levels of reliability (coefficient alphas ranged from 0.848 to 0.940). Validity was supported by high correlations between National Eye Institute Visual Function Questionnaire scales and the new-vision-targeted scales (highest values were 0.771 between psychosocial well-being and mental health, and 0.729 between role performance and role difficulties), and by lower mean scores in those groups self-reporting eye disease (F statistic with p < 0.01 for all comparisons except cataract with ocular symptoms, psychosocial well-being, and role performance scales).

Conclusions

This vision-targeted HRQOL measure provides a basis for comprehensive assessment of the impact of eye diseases and treatments on daily functioning and well-being in adults.

Background

The NIH-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal (GI) Symptoms scales were developed to assess patients' GI symptoms in clinical settings.

Aims

To assess responsiveness to change and provide minimally important difference (MID) estimates for the PROMIS GI Symptoms scales.

Methods

A sample of 256 GI outpatients self-administered the eight PROMIS GI Symptoms scales (gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloating/flatulence) at two visits. Patient self-reported and physician-reported assessments of the subjects' overall GI condition were employed as change anchors. In addition, we prospectively assessed change at both visits using a GI-symptom anchor, the Gastrointestinal Symptom Rating Scale (GSRS). Responsiveness to change was assessed using F-statistics. The minimally changed group was those somewhat better or somewhat worse on the retrospective anchors and changing by one category on the modified GSRS (e.g., from slight to mild discomfort to moderate to moderately severe discomfort).

Results

Responsiveness to change was statistically significant for 6 of 8 PROMIS scales using the self-report GI anchor, 3 of 8 scales using the physician-reported anchor, and 5 of 5 scales using the corresponding GSRS scales as anchors. The MID estimates for scales for improvement and worsening were about 0.5-0.6 SD using the GSRS anchor and generally larger in magnitude than the change for the "about the same" group.

Conclusions

The responsiveness and MID estimates provided here for the PROMIS GI Symptoms scales can aid in scale score interpretation in clinical trials and observational studies.