Cross-cultural adaptation and validation of the NASS outcomes instrument in Spanish patients with low back pain (original) (raw)
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Validation in Colombia of the Oswestry Disability Questionnaire in Patients With Low Back Pain
Spine, 2011
Observational study to validate a scale. Objective. To translate, culturally adapt, and validate the Oswestry Disability Index (ODI), version 2.1a. Summary of Background Data. The ODI is one of the most frequently used tools to evaluate disability in patients with low back pain. Its psychometric properties have shown to be highly reliable. Currently, no validated Colombian version is available. Methods. The ODI (2.1a) was translated into Spanish and this translated version was analyzed in terms of semantic and linguistic equivalence. Then, the Spanish version was translated back into English. The fi rst time, the ODI was administered to a total of 111 patients with back pain. Internal consistency, construct validity, content validity and criterion validity were evaluated for the scale. The inter-rater reliability was evaluated by 2 different observers a day apart from each other and the intra-rater reliability was determined by the same observer, 7 days apart. A sensitivity-to-change analysis was performed on 81 patients. Results. Of the sample, 67.6% were women, with a mean (SD) age of 44.88 (16.38) years. Cronbach alpha coeffi cient was 0.86. Inter-rater reliability yielded an intraclass correlation coeffi cient (ICC) of 0.94 whereas intrarater reliability yielded an ICC of 0.95. Pearson correlation between ODI and each of the 8 domains of SF-36, was statistically signifi cant. Construct validity, when comparing extremely acute and chronic groups, did not show any differences (P = 0.409). Concurrent criterion validity between ODI and Roland-Morris Disability Questionnaire (RMQ) was r = 0.75; between ODI and the Visual Analog Scale (VAS) was r = 0.540. For patients who received an intervention, the value of this change was 1.2. Conclusion. ODI-C is a helpful, reliable and valid tool in Colombia for back pain patient follow-up and assessment, regardless the stage of the evolution. It is an observational study to validate the Oswestry M oderate back pain of moderate duration occurs with an annual incidence ranging from 10% to 15% in an adult population and prevalence between 15% and 30%. Out of the total acute episodes, 90% subside spontaneously during the fi rst 3 months, but the remaining 10% show a slow recovery and require long-term treatment with the consequent economic demand of the health system. 1 The most frequently studied outcomes in back pain research and clinical practice are: pain, disability, work resumption, and life quality. These variables are evaluated through patientcentered scales. They have been used in studies of back pain treatment with nonsteroidal anti-infl ammatory (NSAID), 2 comparing NSAI drugs, 3 opioids, 4 muscle relaxants, 5 different routes of administration of medication, nonpharmacological treatment, 6-8 alternative therapies, 9 , 10 educational programs, 11 and physical means, among others. For a general pain assessment, the most commonly used measurement instrument is the visual analog scale (VAS). 12 A reduction of at least 20 mm 13 is considered statistically signifi cant. Two of the most commonly used self-report questionnaires to assess back pain are the Oswestry Disability Index (ODI) and the Roland-Morris Disability Questionnaire (RMDQ). 14 Four versions of the ODI are available in English. Version 1.0 was published in 1980 by its author Jeremy Fairbank 15 and it was extensively distributed by the International Society for the Study of the Lumbar Spine (ISSLS) in Paris. A new ODI version was adapted in 1989 by the Chiropractic College in England. The American Academy of Orthopedic Surgeons and other spine associations adapted the ODI 1.0 version in 1996 omitting categories 1, 8, and 9. This version is included in the assessment protocol proposed by the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS), which brings together the main international spine associations. Version 2.0 was modifi ed by the Medical Research Council Group in the United Kingdom in 1996 16 and they omitted the word "painkillers" in the fi rst category. Version 2.1a is the most recent and recommended
Study Design: Cross-sectional study. Purpose: This study aimed to cross-culturally translate and validate the low back outcome score (LBOS) in Iran. Overview of Literature: Lumbar disc hernia (LDH) is the most common diagnoses of low back pain and imposes a heavy burden on both individual and society. Instruments measuring patient reported outcomes should satisfy cetain psychometric properties. Methods: The translation and cross-cultural adaptation of the original questionnaire was performed using Beaton's guideline. A total of 163 patients with LDH were asked to respond to the questionnaire at three points in time: preoperative and twice within 1-week interval after surgery assessments. The Oswestry disabilty index (ODI) was also completed. The internal consistency, test-retest, convergent validity, and responsiveness to change were assessed. Responsiveness to change also was assessed comparing patients' pre-and postoperative scores. Results: The mean age of the cohort was 49.8 years (standard deviation=10.1). The Cronbach's alpha coefficients for the LBOS at preoperative and postoperative assessments ranged from 0.77 to 0.79, indicating good internal consistency. Test-retest reliability as performed by intraclass correlation coefficient was found to be 0.82 (0.62–0.91). The instrument discriminated well between subgroups of patients who differed in the Finneson-Cooper score. The ODI correlated strongly with the LBOS score, lending support to its good convergent validity (r=–0.83; p<0.001). Further analysis also indicated that the questionnaire was responsive to change (p<0.001). Conclusions: The Iranian version of LBOS performed well and the findings suggest that it is a valid measure of back pain treatment evaluation among LDH patients.
Low Back Pain Rating scale: validation of a tool for assessment of low back pain
Pain, 1994
LOW Back Pain Rating scale is an index scale which includes measurements of pain intensity, disability, and physical impairment. The scale was designed to monitor the outcome of clinical trials of low back pain treatment. It has been validated in 58 patients following first-time discectomy. The scale rating can be rapidly carried out and requires no special aids. With slight modification it can be used in office and telephone interviews, as well as postal questionnaires. These modifications only slightly reduce the quantity of information gathered. In the study, a high rater agreement (97.7%) was found without level difference between two observers using the scale. The validation process included: construct validity, criterion-related validity and item bias, relative to Global Assessments pronounced by the patient and an experienced clinician. Low Back Pain Rating scale has been shown to be valid and reliable in the assessment of low back pain.
Self-Report Outcome Measures for Low Back Pain
Spine, 2007
Objectives. To describe the available cross-cultural adaptations of low back pain (LBP) self-report outcome measures and the psychometric testing that has occurred for each adaptation.
The clinical importance of changes in outcome scores after treatment for chronic low back pain
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2003
When measuring treatment effect in chronic low back pain with multi-item outcome instruments, it is necessary, both for clinical decision-making and research purposes, to understand the clinical importance of the outcome scores. The aims of the present study were three-fold. Firstly, it aimed to estimate the minimal clinically important difference of three multi-item outcome instruments (the Oswestry Disability Index, the General Function Score and the Zung Depression Scale) and of the visual analogue scale (VAS) of back pain. Secondly, it aimed to estimate the error of measurement of these instruments; and its third aim was to describe the clinical meaning of score change. The study population consisted of 289 patients treated surgically or non-surgically in a randomised controlled trial. The minimal clinically important difference was estimated with patient global assessment as the external criterion. It was compared with the standard error of measurement of the instruments. The i...
Medicina, 2009
Objective. This prospective observational study of the Short-Form Health Survey (SF-36), Oswestry Disability Index, Lithuanian version of the McGill Pain Questionnaire, and Visual Analogue Scale (VAS) for pain was performed to evaluate their effectiveness in the additional preoperative screening of patients with disc herniation disease. Patients and methods. In the present study, we investigated a cohort of 100 patients with lumbar disc herniation causing low back pain and the second one of 100 patients with nonspecific low back pain by applying physical activity, pain scales and Short-Form 36 General Health Questionnaire. Results. The quantitative analysis of SF-36 domain scores showed the substantial differences in both examined (herniated and control) groups. In the present study, we estimated moderate but statistically significant (P<0.05) correlations between the bodily pain domain scores and assessment of back and leg pain on the VAS, as well as between the physical functio...
Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain
Pain medicine (Malden, Mass.), 2017
To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims. Literature review of existing PRO measures. Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes. Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris...
Outcome assessment in low back pain: how low can you go?
European Spine Journal, 2005
The present study examined the psychometric characteristics of a ''core-set'' of six individual questions (on pain, function, symptom-specific well-being, work disability, social disability and satisfaction) for use in low back pain (LBP) outcome assessment. A questionnaire booklet was administered to 277 German-speaking LBP patients with a range of common diagnoses, before and 6 months after surgical (N=187) or conservative (N=90) treatment. The core-set items were embedded in the booklet alongside validated 'reference' questionnaires: Likert scales for back/leg pain; Roland and Morris disability scale; WHO Quality of Life scale; Psychological General Well-Being Index. A further 45 patients with chronic LBP completed the booklet twice in 1-2 weeks. The minimal reliability (similar to Cronbach's alpha) for each core item was 0.42-0.78, increasing to 0.84 for a composite index score comprising all items plus an additional question on general well-being ('quality of life'). Floor or ceiling effects of 20-50% were observed for some items before surgery (function, symptom-specific well-being) and some items after it (disability, function). The intraclass correlation coefficient (ICC) (''test-retest reliability'') was moderate to excellent (ICC, 0.67-0.95) for the individual core items and excellent (ICC, 0.91) for the composite index score. With the exception of ''symptom-specific well-being'', the correlations between each core item and its corresponding reference questionnaire (''validity'') were between 0.61 and 0.79. Both the composite index and the individual items differentiated (P<0.001) between the severity of the back problem in surgical and conservative patients (validity). The composite index score had an effect size (sensitivity to change) of 0.95, which was larger than most of the reference questionnaires (0.47-1.01); for individual core items, the effect sizes were 0.52-0.87. The core items provide a simple, practical, reliable, valid and sensitive assessment of outcome in LBP patients. We recommend the widespread and consistent use of the core-set items and their composite score index to promote standardisation of outcome measurements in clinical trials, multicentre studies, routine quality management and surgical registry systems.
Minimal clinically important difference. Low back pain: outcome measures
The Journal of rheumatology, 2001
A proposed standard "core set" of outcome measures for low back pain includes 5 domains: back-specific function, generic health status, pain, work disability, and patient satisfaction. This paper focuses on the 2 recommended back-specific measures of function: the Roland-Morris Disability Questionnaire (RDQ) and the Oswestry Disability Index (ODI). We specifically address their ability to measure change. A systematic review of the literature identified a total of 78 and 71 (RDQ and ODI, respectively) articles as potentially relevant. Detailed tables are provided for each citation, with the type of back pain population studied, the type of change measured, the estimate of change, and the interval over which the change was studied. These tables should be used as a reference for sample size calculation. The responsiveness of the RDQ found in the literature ranges from 2 to 8 points on its 0 to 24 scale depending on what change is being measured. As a rough guide, Roland recom...
Outcome Measures for Low Back Pain Research
Spine, 1998
Study Design. An international group of back pain researchers considered recommendations for standardized measures in clinical outcomes research in patients with back pain. Objectives. To promote more standardization of outcome measurement in clinical trials and other types of outcomes research, including meta-analyses, cost-effectiveness analyses, and multicenter studies. Summary of Background Data. Better standardization of outcome measurement would facilitate comparison of results among studies, and more complete reporting of relevant outcomes. Because back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, function, general well-being, work disability, and satisfaction with care. Methods. The panel considered several factors in recommending a standard battery of outcome measures. These included reliability, validity, responsiveness, and practicality of the measures. In addition, compatibility with widely used and promoted batteries such as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to minimize the need for changes when these instruments are used. Results. First, a six-item set was proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and for research purposes. An expanded outcome set, which would provide more precise measurement for research purposes, includes measures of severity and frequency of symptoms, either the Roland or the Oswestry Disability Scale, either the SF-12 or the EuroQol measure of general health status, a question about satisfaction with symptoms, three types of "disability days," and an optional single item on overall satisfaction with medical care. Conclusion. Standardized measurement of outcomes would facilitate scientific advances in clinical care. A short, 6item questionnaire and a somewhat expanded, more precise battery of questionnaires can be recommended. Although many considerations support such recommendations, more data on responsiveness and the minimally important change in scores are needed for most of the instruments.