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.

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.

Importance

Patient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed.

Objective

To develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input.

Design, setting, and participants

The Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1. PROWL-1 began in August 2011 and was completed May 30, 2014; PROWL-2 began in July 2012 and was completed June 27, 2014. Data were analyzed from June 28, 2014, to October 24, 2016.

Main outcomes and measures

Scales assessing visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery. Items from the National Eye Institute (NEI) Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), and the Ocular Surface Disease Index (OSDI) were included. All scales are scored on a 0 to 100 possible range. Construct validity and responsiveness to change were evaluated (comparing scores before and after surgery).

Results

The median age of the 240-person PROWL-1 analytic sample was 27 years (range, 21-52 years); 49 were women (20.4%). The median age of the 271-person PROWL-2 analytic sample was 30 years (range, 21-57 years); 147 were women (54.2%). Internal consistency reliabilities for the 4 visual symptom scales ranged from 0.96 to 0.98 in PROWL-1 and from 0.95 to 0.97 in PROWL-2. The median (interquartile range) test-retest intraclass correlation was 0.69 (0.57-0.79) and 0.76 (0.68-0.84) in PROWL-1 and PROWL-2, respectively. Product-moment correlations of satisfaction with surgery with visual symptom scales at follow-up evaluations ranged from r = 0.24 to r = 0.49. Measures improved from baseline to follow-up, with effect sizes of 0.14 to 1.98, but scores on the NEI-RQL-42 glare scale worsened at the 1-month follow-up. Hours of work did not change significantly from baseline to 1-month follow-up, with the mean number (mean [SD] difference) in PROWL-1 of 41.7 vs 40.9 hours (-0.8 [18.7]) and in PROWL-2 of 38.8 vs 38.2 hours (-0.6 [17.1]).

Conclusions and relevance

The results of these studies support the reliability and validity of visual symptom scales to evaluate the effects of LASIK surgery in future studies.