Dataset Information

Responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders.

ABSTRACT:

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.

SUBMITTER: Hung M

PROVIDER: S-EPMC6309663 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders.

Hung Man M Saltzman Charles L CL Voss Maren W MW Bounsanga Jerry J Kendall Richard R Spiker Ryan R Lawrence Brandon B Brodke Darrel D

The spine journal : official journal of the North American Spine Society 20180630 1

<h4>Background context</h4>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.<h4>Purpose</h4>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).<h4>Study ...[more]

PMID: 29969730

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Project description:Background contextWhen different health care providers use different patient-reported outcome (PRO) instruments, it is challenging to integrate findings that describe particular patient groups or to establish treatment effectiveness across studies. It is therefore critical to develop accurate ways to convert scores between various instruments for clinicians and researchers to make comparisons across health outcomes.PurposeTo develop a common metric so that scores on the Oswestry Disability Index (ODI) and scores on the PROMIS Physical Function can be converted interchangeably.Study design/settingData were collected from a prospective study. A single-group linking design was used.Patient sampleThe study population included 9020 patients presented to an orthopedic spine clinic from November 2013 to March 2019.Outcome measuresPatients completed the ODI and the PROMIS Pain Interference scale delivered by Computerized Adaptive Testing (CAT) at the same time prior to their visit with a spine clinician.MethodsEquipercentile linking methods based on log-linear smoothing approach and non-smoothing approach were used to establish a common metric across the two measures.ResultsThe two measures assess the similar contruct of pain. The correlation between the scores of the ODI and the PROMIS PI was 0.81. The standardized Root Expected Mean Square Difference (REMSD) values for gender, ethnic, and racial groups ranged from 3.55% to 4.81%. Hence, the assumptions for the equipercentile linking method were met. The crosswalk derived linked scores based on the log-linear smoothing method yielded small deviations (Δ = 0.09) from the observed scores. We then identified linked PROMIS-PI scores corresponding to the benchmark ODI scores for the five disability levels and for various categories of patients.ConclusionsThis study is the first to create crosswalks to interchangeably convert scores between the ODI to the PROMIS-PI in a large population of spine patients using the equipercentile linking method. The results of this study provide confidence in the validity and usefulness of the derived crosswalks based on the equipercentile linking approach. The crosswalks are helpful for comparing new and old studies on the two measures and identifying benchmark scores for various diseases and disability levels.

Project description:BackgroundOswestry Disability Index (ODI) is broadly used in clinical and research settings for assessing the disability level in patients with lumbar radiculopathy but it has not been translated into Urdu language according to the pre-established translation guidelines as well as the validity and reliability of ODI Urdu version has not been tested yet. The aim of this study was to translate ODI in native Urdu language (ODI-U) according to recommended guidelines and to measure its psychometric properties in Urdu speaking patients suffering from lumber radiculopathy.MethodsOut of 108 participants, 54 were healthy (who filled ODI-U) and 54 were patients of lumber radiculopathy. The patients were administered through ODI-U, visual analogue scales for disability (VAS disability), pain intensity (VAS pain) and SF-36 at baseline and after 3 days. Reliability was investigated through test-retest method, internal consistency, standard error of measurement (SEM) and smallest detectable change (SDC). ODI-U was assessed for exploratory factor analysis, construct (convergent and discriminative) validity and content validity. Alpha level < 0.05 was considered statistically significant and psychometric standards were evaluated contrary to priori hypothesis.ResultsODI-U revealed excellent test-retest reliability for total score (ICC2,1 = 0.95) and for all item (ICC2,1 = 0.72-0.98). Cronbach's alpha of 0.89 showed excellent internal consistency and moderate correlation between ODI-U total score and each item through spearman's correlation coefficient (r = 0.51-0.76). One factor structure was created, explaining 52.5% variance. There was no floor and ceiling effect of total ODI-U score. Content validity was assessed through conducting interviews with patients and incorporating expert's opinions. The discriminative validity was measured by independent sample t-test, where significant difference between healthy and patients (P < 0.001) was observed. The convergent validity was evaluated through Pearson's correlation showing moderate positive correlation of ODI-U with VAS pain (r = 0.49) and VAS disability (r = 0.51) but moderate negative correlation with all SF-36 domains (r = - 0.43to - 0.63).ConclusionODI-U showed adequate psychometric properties. ODI-U was found to be a reliable and a valid tool to measure the level of disability in Urdu-speaking patients with lumber radiculopathy.

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:STUDY DESIGN:Cross-cultural adaptation and psychometric evaluation. OBJECTIVE:The aim of this study was to translate the Neck Disability Index (NDI) into the simplified-Chinese language and to evaluate the reliability, validity, and responsiveness of the new questionnaire. SUMMARY OF BACKGROUND DATA:Neck pain is a major health problem resulting in major disability. NDI is the most frequently used scale for self-rating of disability due to neck pain. At present, there is no simplified-Chinese version of the NDI. The aims of this study were to culturally adapt and translate the NDI into the simplified-Chinese language (NDI-SC) and to evaluate its psychometric properties in patients with neck pain. METHODS:The NDI was translated into simplified-Chinese version based on established guidelines. A total of 70 patients participated in this study. Patients were asked to complete a set of questionnaires comprising of their demographic information, the NDI-SC, and a visual analog scale (VAS) of pain. Fifty-six patients returned after 1 to 2 weeks to complete the same set of questionnaires and the global rating of change (GROC) scale. Then, the NDI-SC was evaluated for content validity, construct validity, internal consistency, test-retest reliability, and responsiveness. RESULTS:The NDI-SC demonstrated excellent internal consistency (Cronbach ??=?0.92) and good test-retest reliability (ICC2,1?=?0.85). Content validity was confirmed as no floor or ceiling effects were detected for the NDI-SC total score. Construct validity was established with factor analysis revealing two-factor subscales explaining 66% of the variance. The NDI-SC showed a strong correlation with VAS (Rp?=?0.61, P?<?0.001) and a moderate correlation with GROC (Rs?=?0.46, P?<?0.001). The correlation between NDI-SC change scores and VAS change scores was also moderate (Rp?=?0.59, P?<?0.001). CONCLUSION:The results showed that the NDI-SC is a reliable, valid, and responsive instrument to measure functional limitations in patients with neck pain. LEVEL OF EVIDENCE:3.

Project description:PurposePatient-reported outcome measurements (PROMs) are widely used in spine care. The development of reliable and valid National versions of spine-related disability questionnaires is strongly recommended from both the clinical and scientific points-of-view. The aims of this study were to adapt and validate the Oswestry Disability Index (ODI) and the Quebec back pain disability scale (QDS) for use with the Hungarian language.MethodsAfter translating and culturally adapting the ODI and QDS, 133 patients with lumbar degenerative spinal disorder filled in the questionnaire booklet twice within 2 weeks. Subjects completed the Hungarian versions of the two PROMs as well as the WHOQoL-BREF validated as a general life quality questionnaire and Visual Analogue Scale of pain. Internal consistency, reliability and construct validity of the questionnaires were determined, as were the standard error of measurement (SEM) and minimal detectable change (MDC) scores.ResultsThe Hungarian ODI consisted of one factor that showed good internal consistency (Cronbach-α 0.890). The QDS showed a four-factor structure with Cronbach-α values between 0.788 and 0.917. No significant floor or ceiling effects were observed. The test-retest analysis showed excellent reliability of the Hungarian ODI and QDS. The intraclass correlation coefficients (ICC) were 0.927 and 0.923, respectively. SEM values of 4.8 and 5.2 resulted in a MDC of 13 and 14 points in the Hungarian ODI and QDS, respectively. The correlation coefficient (r) between pain and ODI was 0.680 (p < 0.001) and the correlation between the ODI and the physical subscale of WHOQoL was also very good (r = -0.705, p < 0.001). The QDS total score and its four subscales correlated significantly with pain and with the physical subscale of WHOQoL (r > 0.4, p < 0.001). The level of disability measured by the Hungarian ODI and QDS was significantly higher in the surgical subgroup than in non-surgically treated patients (p < 0.001).ConclusionsTranslation and cultural adaptation of the ODI and QDS were successful. Hungarian versions of the ODI and QDS proved to be reliable, valid PROMs confirming that they can be used in future clinical and scientific work with Hungarian-speaking spine patients.

Dataset Information

Responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders.

Background context

Purpose

Study design/setting

Patient sample

Outcome measures

Methods

Results

Conclusion

Publications

Responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders.

Similar Datasets

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