Dataset Information

Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

ABSTRACT: Objective:The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. Design:Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. Setting:Dual site, university-based outpatient clinics. Subjects:Women aged 20 to 67 years diagnosed with fibromyalgia. Methods:Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. Results:PROMIS static SF instruments had fair to high internal consistency (Cronbach ??=?0.58 to 0.94, P ?

SUBMITTER: Merriwether EN

PROVIDER: S-EPMC6279305 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

Merriwether Ericka N EN Rakel Barbara A BA Zimmerman Miriam B MB Dailey Dana L DL Vance Carol G T CGT Darghosian Leon L Golchha Meenakshi M Geasland Katherine M KM Chimenti Ruth R Crofford Leslie J LJ Sluka Kathleen A KA

Pain medicine (Malden, Mass.) 20170801 8

<h4>Objective</h4>The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia.<h4>Design</h4>Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimu ...[more]

PMID: 27561310

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Project description:The psychometric properties of Patient Reported Outcomes Measurement Information System (PROMIS) instruments have been explored in a number of general and clinical samples. No study, however, has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis (KOA). The aim of this project was to evaluate the construct (structural) validity and floor/ceiling effects of four PROMIS measures in this population.We conducted a secondary analysis of baseline data from a randomized trial comparing Tai Chi and physical therapy. Participants completed four PROMIS static short-form instruments (i.e., Anxiety, Depression, Physical Function, and Pain Interference) as well as six well-validated (legacy) measures that assess pain, function, and psychological health. We calculated descriptive statistics and percentages of participants scoring the minimum (floor) and maximum (ceiling) possible scores for PROMIS and legacy measures. We also estimated the association between PROMIS scores and scores on legacy measures using Spearman's rank correlations coefficients.Data from 204 participants were analyzed. Mean age of the sample was 60 years; 70% were female. The PROMIS Anxiety and Depression had floor effects with 17 and 24% of participants scoring the minimum, respectively. PROMIS Anxiety and Depression scores had strongest associations with general mental health, including stress (Perceived Stress Scale, r???0.65) and depression (Beck Depression Index-II, r?=?0.70). PROMIS Pain Interference scores correlated most strongly with measures of whole body pain (Short-Form 36 Bodily Pain, r?=?-0.73) and physical health (Short-Form 36 Physical-Component Summary, r?=?-0.73); their correlations were lower with other legacy measures, including with the WOMAC knee-specific pain (r?=?0.47). PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function (r?=?0.79) than with scores on other legacy measures.The four PROMIS static-short forms performed well among individuals with symptomatic knee osteoarthritis as evidenced in correlations with legacy measures. PROMIS Anxiety and Depression target general mental health (e.g., stress, depression), and PROMIS Pain Interference and Physical Function static-short forms target whole-body outcomes among participants with symptomatic knee osteoarthritis. Floor effects in the PROMIS Anxiety and Depression scores should be considered if needing to distinguish among patients with very low levels of these outcomes.Clinicaltrials.gov NCT01258985. Registered 10 December 2010.

Project description:BackgroundLimitations in physical functioning are a big concern especially for patients with chronic or musculoskeletal diseases. Therefore, physical functioning is often used as a core outcome of treatments. The generic patient-reported outcomes information system (PROMIS) physical function (PF) item bank has shown potential to measure PF with better precision, interpretability and lower respondent burden compared with traditional patient-reported outcome measures. This study provides an overview of the current evidence on the quality of the measurement properties of the translated Dutch-Flemish PROMIS-PF item bank and its subdomains, and their derived short forms and computer adaptive tests (CATs).MethodsPubMed was searched up to June 17th 2020 for validation studies of Dutch-Flemish PROMIS-PF in Dutch and Flemish adults. Quality assessment of the included studies was conducted using the COSMIN Risk of bias checklist. The COSMIN criteria for good measurement properties were used to judge the results of the studies, which were adjusted and added to where needed for this review, in the context of IRT instruments and item banks. The quality of evidence was summarized for each measurement property based on the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach.ResultsEleven studies were included, evaluating the PROMIS-PF item bank, the Upper Extremity (UE) subdomain, and/or their derived short forms and CATs in different clinical populations. There is evidence for sufficient structural validity, measurement precision, construct validity, and cross-cultural validity of the Dutch-Flemish PROMIS-PF item bank. The upper extremity subdomain item bank shows high quality evidence for structural validity and measurement precision. Content validity of these item banks has not been thoroughly demonstrated in a Dutch-Flemish population. Furthermore, the derived instruments have far less robust evidence: there are fewer validation studies available and none examined their performance as stand-alone administered instruments.ConclusionsThe first studies into the Dutch-Flemish PROMIS-PF item bank and the UE subdomain show promising results, with especially high quality evidence for sufficient structural validity and measurement precision. However, more studies, and with higher methodological quality, are needed to study the instruments derived from these item banks. These studies should also evaluate content validity, reliability and responsiveness.

Project description:BACKGROUND CONTEXT:The Patient-Reported Outcomes Information System (PROMIS) instruments are an important advancement in the use of PROs, but need to be evaluated with longitudinal data to determine whether they are responsive to change in specific clinical populations. PURPOSE:The purpose of this study was to assess the responsiveness of the PROMIS Physical Function (PF), PROMIS Pain Interference (PI), Neck Disability Index (NDI), and the Oswestry Disability Index (ODI). STUDY DESIGN/SETTING:This study entailed prospective data collection from consecutive patients aged 18 and older, visiting a university-based orthopaedic spine clinic between October 2013 and January 2017. PATIENT SAMPLE:A total of 763 participants in the sample had a mean age of 58 (SD?=?15) years and the sample was 50.2% male and 92.8% Caucasian. OUTCOME MEASURES:The PROMIS PF and PROMIS PI Computerized Adaptive Tests along with either the NDI or ODI instruments were administered on tablet computers before clinic visits. Global rating of change questions relating to pain and function levels was also administered. METHODS:Baseline scores were compared with follow-up scores at four different time-points from 3-months to 6-months and beyond. Patient demographics, mean scores, paired-sample t tests, Standardized Response Mean (SRM), and Effect Size (ES) were analyzed to determine instrument responsiveness. This project was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number U01AR067138 and the authors have no conflicts of interest to disclose. RESULTS:The PROMIS instruments were strongly correlated with each other as well as with the NDI and ODI. Responsiveness was significant on all four instruments at every time-point assessed (paired sample t tests ranged from p?<?.001 to p?=?.049). SRM's were large and over 0.94 for every instrument at every time-point. Cohen's d ES were large and over 0.96 for all at all time-points, except for the NDI which had ES ranging from 0.74 to 0.83. This study showed large effect sizes and responsiveness of the PROMIS PF, PROMIS PI, NDI and ODI in a population of orthopaedic patients with spine pathologies. CONCLUSION:This study demonstrates strong responsiveness of the PROMIS PF and PROMIS PI in a spine clinic population.

Dataset Information

Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

Publications

Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

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